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Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02796651
Recruitment Status : Completed
First Posted : June 13, 2016
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease - COPD
Interventions Drug: Formoterol fumarate (6 μg)
Drug: Formoterol furmarate (20 μg)
Drug: Placebo for formoterol fumarate
Drug: Formoterol fumarate (12 μg)
Drug: Formoterol fumarate (40 μg)
Enrollment 132
Recruitment Details This study was carried on 132 participants with moderate to severe chronic obstructive pulmonary disease (COPD) & reversible airway disease in the United States of America (USA; 21 sites) & were randomized to one of treatment sequences (each with 5 periods of different treatment, separated by wash-out period of 7 (+/1) days after treatment period).
Pre-assignment Details After signature of the informed consent, participants who were taking prohibited medication performed a wash-out period and were given Atrovent (2 puffs 4 times/day) before Screening and during the run-in period. All participants were provided with rescue drug (albuterol) and Atrovent to be taken during the wash-out between treatment periods.
Arm/Group Title Total Participants
Hide Arm/Group Description

All patients were randomized in a treatment sequence containing 5 treatment periods. All patients received FF12 and Perforomist 20 mcg, 90% received FF6, FF24 and Perforomist 40 mcg, and only 30% received placebo. Treatment was double blind for FF in Pressair, and open label for Perforomist. If treatment was FF6, FF12, FF24 or placebo, patients received two identical Pressair dry powder inhalers (DPI) and were instructed to take 1 puff from each of the inhalers in the morning and in the evening for 7 days. If treatment was Perforomist 20 mcg, patients were instructed to take 1 vial in the morning and 1 vial in the evening for 7 days. Treatment with Perforomist 40 mcg was a single dose administration.

Note: 132 participants were randomized. But, one participant was excluded from the ITT analysis set as the participant did not have a post-baseline forced expiratory volume in 1 second (FEV1) measurement.

Period Title: Overall Study
Started 132
Formoterol Fumarate (FF) 6 μg [1] 107
Formoterol Fumarate (FF) 12 μg [2] 121
Formoterol Fumarate (FF) 24 μg [3] 105
Perforomist 20 μg [4] 118
Perforomist 40 μg [5] 108
Placebo (Lactose Monohydrate) [6] 38
Completed 106
Not Completed 26
Reason Not Completed
Adverse Event             6
Lost to Follow-up             1
Withdrawal by Subject             4
Protocol Violation             4
Lack of Efficacy             1
Not specified             10
[1]
Participants had 1 puff each from 2 identical Pressair DPI (FF 6μg & placebo) in morning & evening
[2]
Participants had 1 puff each from 2 identical Pressair DPI (FF 12μg & placebo) in morning & evening
[3]
Participants had 1 puff each from 2 identical Pressair DPI (FF 24μg & placebo) in morning & evening
[4]
Participants took 1 vial of Perforomist 20μg oral nebulization solution in morning & evening
[5]
Participants took 1 dose of 2 vials of Perforomist 20μg oral nebulization solution on Day 1 morning
[6]
Participants had 1 puff from Pressair DPI (FF 6/12/24 μg matching placebo) in morning & evening
Arm/Group Title Overall Study Total
Hide Arm/Group Description

All patients were randomized in a treatment sequence containing 5 treatment periods. All patients received FF12 and Perforomist 20 mcg, 90% received FF6, FF24 and Perforomist 40 mcg, and only 30% received placebo. Treatment was double blind for FF in Pressair, and open label for Perforomist. If treatment was FF6, FF12, FF24 or placebo, patients received two identical Pressair DPI and were instructed to take 1 puff from each of the inhalers in the morning and in the evening for 7 days. If treatment was Perforomist 20 mcg, patients were instructed to take 1 vial in the morning and 1 vial in the evening for 7 days. Treatment with Perforomist 40 mcg was a single dose administration.

Note: 132 participants were randomized. But, one participant was excluded from the ITT analysis set as the participant did not have a post-baseline forced expiratory volume in 1 second (FEV1) measurement.

Overall Number of Baseline Participants 131
Hide Baseline Analysis Population Description
The ITT analysis set: Consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant’s adherence to the randomized treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants
62.3  (7.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 131 participants
<50 years 5
≥50 to <65 years 78
≥65 years 48
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants
Female
66
  50.4%
Male
65
  49.6%
1.Primary Outcome
Title Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on Treatment
Hide Description

To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate(20 μg).

Pre-dose spirometry was performed before the morning daily dose at Day 1 and Day 7 of each treatment period. Two sets of measurements were performed during the hour preceding the scheduled morning study drug administration, allowing approximately 30 minutes between them.

Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.

Time Frame Day 7: 30 min, 1 to 4 hours, 6 hours, 9 hours and 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant’s adherence to the randomized treatment.
Arm/Group Title Formoterol Fumarate 6 μg Formoterol Fumarate (FF) 12 μg Formoterol Fumarate (FF) 24 μg Perforomist 20 μg Placebo (Lactose Monohydrate)
Hide Arm/Group Description:
Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days
Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days
Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
Overall Number of Participants Analyzed 105 118 104 116 35
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Litre/Hour
0.108
(0.073 to 0.143)
0.117
(0.082 to 0.151)
0.161
(0.125 to 0.197)
0.122
(0.087 to 0.156)
0.000
(-0.055 to 0.054)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.108
Confidence Interval (2-Sided) 95%
0.055 to 0.161
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 12 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.117
Confidence Interval (2-Sided) 95%
0.064 to 0.171
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 24 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.162
Confidence Interval (2-Sided) 95%
0.107 to 0.216
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Perforomist 20 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.122
Confidence Interval (2-Sided) 95%
0.069 to 0.175
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Formoterol Fumarate (FF) 12 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.556
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.009
Confidence Interval (2-Sided) 95%
-0.021 to 0.039
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Formoterol Fumarate (FF) 24 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.053
Confidence Interval (2-Sided) 95%
0.021 to 0.085
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Perforomist 20 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.365
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.014
Confidence Interval (2-Sided) 95%
-0.016 to 0.044
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 12 μg, Formoterol Fumarate (FF) 24 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.044
Confidence Interval (2-Sided) 95%
0.013 to 0.076
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 12 μg, Perforomist 20 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.756
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.005
Confidence Interval (2-Sided) 95%
-0.026 to 0.036
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 24 μg, Perforomist 20 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -0.039
Confidence Interval (2-Sided) 95%
-0.071 to -0.008
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in FEV1 AUC0-6/6h at Day 1 on Treatment
Hide Description To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg and 40 μg). 6-hour serial spirometry was performed at Day 1 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose.
Time Frame Day 1: zero time to 6 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant’s adherence to the randomized treatment.
Arm/Group Title Formoterol Fumarate 6 μg Formoterol Fumarate (FF) 12 μg Formoterol Fumarate (FF) 24 μg Perforomist 20 μg Perforomist 40 μg Placebo (Lactose Monohydrate)
Hide Arm/Group Description:
Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days
Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days
Randomized participants received single dose of 2 vials of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning of Day 1 of assigned treatment period.
Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
Overall Number of Participants Analyzed 106 121 104 118 108 38
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Litre/Hour
0.111
(0.077 to 0.145)
0.148
(0.115 to 0.182)
0.205
(0.171 to 0.239)
0.195
(0.162 to 0.229)
0.246
(0.212 to 0.280)
-0.019
(-0.063 to 0.025)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.130
Confidence Interval (2-Sided) 95%
0.091 to 0.169
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 12 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.167
Confidence Interval (2-Sided) 95%
0.128 to 0.206
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 24 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.224
Confidence Interval (2-Sided) 95%
0.184 to 0.263
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Perforomist 20 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.214
Confidence Interval (2-Sided) 95%
0.176 to 0.253
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Perforomist 40 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.265
Confidence Interval (2-Sided) 95%
0.226 to 0.304
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Formoterol Fumarate (FF) 12 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.037
Confidence Interval (2-Sided) 95%
0.012 to 0.062
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Formoterol Fumarate (FF) 24 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.094
Confidence Interval (2-Sided) 95%
0.068 to 0.119
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Perforomist 20 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.084
Confidence Interval (2-Sided) 95%
0.059 to 0.110
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Perforomist 40 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.135
Confidence Interval (2-Sided) 95%
0.109 to 0.161
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 12 μg, Formoterol Fumarate (FF) 24 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.057
Confidence Interval (2-Sided) 95%
0.031 to 0.082
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 12 μg, Perforomist 20 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.047
Confidence Interval (2-Sided) 95%
0.023 to 0.071
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 12 μg, Perforomist 40 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.098
Confidence Interval (2-Sided) 95%
0.073 to 0.123
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 24 μg, Perforomist 20 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.469
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -0.009
Confidence Interval (2-Sided) 95%
-0.035 to 0.016
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 24 μg, Perforomist 40 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.041
Confidence Interval (2-Sided) 95%
0.015 to 0.068
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Perforomist 20 μg, Perforomist 40 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.051
Confidence Interval (2-Sided) 95%
0.025 to 0.076
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in FEV1 AUC0-6/6h at Day 7 on Treatment
Hide Description To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). 6-hour serial spirometry was performed at Day 7 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation
Time Frame Day 7: zero time to 6 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant’s adherence to the randomized treatment.
Arm/Group Title Formoterol Fumarate 6 μg Formoterol Fumarate (FF) 12 μg Formoterol Fumarate (FF) 24 μg Perforomist 20 μg Placebo (Lactose Monohydrate)
Hide Arm/Group Description:
Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days
Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days
Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
Overall Number of Participants Analyzed 105 119 104 117 36
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Litre/Hour
0.166
(0.127 to 0.205)
0.177
(0.139 to 0.215)
0.225
(0.186 to 0.265)
0.186
(0.147 to 0.225)
0.007
(-0.050 to 0.064)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.159
Confidence Interval (2-Sided) 95%
0.105 to 0.213
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 12 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.170
Confidence Interval (2-Sided) 95%
0.116 to 0.224
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 24 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.219
Confidence Interval (2-Sided) 95%
0.163 to 0.274
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Perforomist 20 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.179
Confidence Interval (2-Sided) 95%
0.125 to 0.233
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Formoterol Fumarate (FF) 12 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.488
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.011
Confidence Interval (2-Sided) 95%
-0.020 to 0.042
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Formoterol Fumarate (FF) 24 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.060
Confidence Interval (2-Sided) 95%
0.027 to 0.092
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Perforomist 20 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.206
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.020
Confidence Interval (2-Sided) 95%
-0.011 to 0.051
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 12 μg, Formoterol Fumarate (FF) 24 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.049
Confidence Interval (2-Sided) 95%
0.016 to 0.081
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 12 μg, Perforomist 20 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.567
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.009
Confidence Interval (2-Sided) 95%
-0.022 to 0.041
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 24 μg, Perforomist 20 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -0.039
Confidence Interval (2-Sided) 95%
-0.072 to -0.007
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Morning Pre-dose (Trough) FEV1 at Day 7 on Treatment
Hide Description

To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). Trough value was defined as the mean of the 2 pre-dose measurements on Day 7. If 1 of the 2 measurements was missing, the non-missing measurement was used as the trough value.

Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.

Time Frame At baseline and Day 7
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Hide Analysis Population Description
The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant’s adherence to the randomized treatment.
Arm/Group Title Formoterol Fumarate 6 μg Formoterol Fumarate (FF) 12 μg Formoterol Fumarate (FF) 24 μg Perforomist 20 μg Placebo (Lactose Monohydrate)
Hide Arm/Group Description:
Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days
Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days
Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
Overall Number of Participants Analyzed 105 119 104 117 36
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Litre
0.077
(0.044 to 0.109)
0.067
(0.035 to 0.098)
0.102
(0.069 to 0.135)
0.061
(0.029 to 0.092)
0.002
(-0.059 to 0.063)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.075
Confidence Interval (2-Sided) 95%
0.008 to 0.141
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 12 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.065
Confidence Interval (2-Sided) 95%
-0.001 to 0.131
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 24 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.100
Confidence Interval (2-Sided) 95%
0.032 to 0.168
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Perforomist 20 μg, Placebo (Lactose Monohydrate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.059
Confidence Interval (2-Sided) 95%
-0.006 to 0.123
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Formoterol Fumarate (FF) 12 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.615
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -0.010
Confidence Interval (2-Sided) 95%
-0.048 to 0.028
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Formoterol Fumarate (FF) 24 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.209
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.025
Confidence Interval (2-Sided) 95%
-0.014 to 0.065
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate 6 μg, Perforomist 20 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.403
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -0.016
Confidence Interval (2-Sided) 95%
-0.053 to 0.022
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 12 μg, Formoterol Fumarate (FF) 24 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.074
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value 0.035
Confidence Interval (2-Sided) 95%
-0.003 to 0.074
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 12 μg, Perforomist 20 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.750
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -0.006
Confidence Interval (2-Sided) 95%
-0.045 to 0.032
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Formoterol Fumarate (FF) 24 μg, Perforomist 20 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -0.041
Confidence Interval (2-Sided) 95%
-0.080 to -0.003
Estimation Comments [Not Specified]
Time Frame From the time of signature of informed consent throughout the treatment period and including the follow-up period (i.e. 2 weeks after the last IP).
Adverse Event Reporting Description Adverse event: The development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an investigation (e.g., laboratory findings, electrocardiogram)
 
Arm/Group Title Formoterol Fumarate 6 μg Formoterol Fumarate (FF) 12 μg Formoterol Fumarate (FF) 24 μg Perforomist 20 μg Perforomist 40 μg Placebo (Lactose Monohydrate)
Hide Arm/Group Description Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days Randomized participants received single dose of 2 vials of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning of Day 1 of assigned treatment period. Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days
All-Cause Mortality
Formoterol Fumarate 6 μg Formoterol Fumarate (FF) 12 μg Formoterol Fumarate (FF) 24 μg Perforomist 20 μg Perforomist 40 μg Placebo (Lactose Monohydrate)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)   1/121 (0.83%)   0/105 (0.00%)   0/118 (0.00%)   0/109 (0.00%)   0/38 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Formoterol Fumarate 6 μg Formoterol Fumarate (FF) 12 μg Formoterol Fumarate (FF) 24 μg Perforomist 20 μg Perforomist 40 μg Placebo (Lactose Monohydrate)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/107 (0.93%)   2/121 (1.65%)   0/105 (0.00%)   0/118 (0.00%)   1/109 (0.92%)   1/38 (2.63%) 
Cardiac disorders             
Myocardial infarction * 1  0/107 (0.00%)  1/121 (0.83%)  0/105 (0.00%)  0/118 (0.00%)  0/109 (0.00%)  0/38 (0.00%) 
General disorders             
Vascular stent occlusion * 1  0/107 (0.00%)  1/121 (0.83%)  0/105 (0.00%)  0/118 (0.00%)  0/109 (0.00%)  0/38 (0.00%) 
Injury, poisoning and procedural complications             
Multiple injuries * 1  1/107 (0.93%)  0/121 (0.00%)  0/105 (0.00%)  0/118 (0.00%)  0/109 (0.00%)  0/38 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Squamous cell carcinoma of lung * 1  0/107 (0.00%)  0/121 (0.00%)  0/105 (0.00%)  0/118 (0.00%)  1/109 (0.92%)  0/38 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive pulmonary disease * 1  0/107 (0.00%)  0/121 (0.00%)  0/105 (0.00%)  0/118 (0.00%)  0/109 (0.00%)  1/38 (2.63%) 
1
Term from vocabulary, MedDRA version 19.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Formoterol Fumarate 6 μg Formoterol Fumarate (FF) 12 μg Formoterol Fumarate (FF) 24 μg Perforomist 20 μg Perforomist 40 μg Placebo (Lactose Monohydrate)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/107 (2.80%)   4/121 (3.31%)   1/105 (0.95%)   7/118 (5.93%)   0/109 (0.00%)   3/38 (7.89%) 
Infections and infestations             
Upper respiratory tract infection * 1  1/107 (0.93%)  0/121 (0.00%)  0/105 (0.00%)  2/118 (1.69%)  0/109 (0.00%)  0/38 (0.00%) 
Urinary tract infection * 1  2/107 (1.87%)  1/121 (0.83%)  0/105 (0.00%)  1/118 (0.85%)  0/109 (0.00%)  0/38 (0.00%) 
Musculoskeletal and connective tissue disorders             
Muscle spasms * 1  0/107 (0.00%)  0/121 (0.00%)  0/105 (0.00%)  2/118 (1.69%)  0/109 (0.00%)  0/38 (0.00%) 
Nervous system disorders             
Headache * 1  0/107 (0.00%)  3/121 (2.48%)  1/105 (0.95%)  2/118 (1.69%)  0/109 (0.00%)  0/38 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive pulmonary disease * 1  0/107 (0.00%)  0/121 (0.00%)  0/105 (0.00%)  0/118 (0.00%)  0/109 (0.00%)  3/38 (7.89%) 
1
Term from vocabulary, MedDRA version 19.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Leader
Organization: AstraZeneca AB
Phone: +46 766 346712
EMail: clinicaltrialtransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02796651     History of Changes
Other Study ID Numbers: D6571C00002
First Submitted: June 7, 2016
First Posted: June 13, 2016
Results First Submitted: November 30, 2017
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018