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Trial record 16 of 857 for:    ALBUTEROL

Safety Study of Albuterol Spiromax® in Subjects With Asthma

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: NCT01698320
Recruitment Status : Completed
First Posted : October 3, 2012
Results First Posted : August 19, 2015
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Placebo MDPI
Drug: Albuterol MDPI
Enrollment 364
Recruitment Details  
Pre-assignment Details Of the 33 patients who were screened but not enrolled, 28 were excluded on the basis of inclusion/exclusion criteria, 2 patients withdrew consent, and 3 patients were lost to follow-up before the baseline visit.
Arm/Group Title All Enrolled Subjects Placebo MDPI-Albuterol MDPI Albuterol MDPI-Albuterol MDPI
Hide Arm/Group Description Includes subjects who were enrolled in study and participated in the single-blind (subjects were blinded) run-in period in which subjects used the inhaler with placebo and maintained the diary for about one week prior to randomization and starting the 12-week double-blind period.

During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

Period Title: Run-In Period (Week -1 to Day 0)
Started 364 0 0
Completed 337 0 0
Not Completed 27 0 0
Reason Not Completed
Inclusion/exclusion criteria             24             0             0
Withdrawal by Subject             1             0             0
Lost to Follow-up             1             0             0
Not specified             1             0             0
Period Title: 12-Week Double-Blind Period
Started 0 169 168
Safety Population 0 170 [1] 168
Completed 0 165 156
Not Completed 0 4 12
Reason Not Completed
Adverse Event             0             1             1
Withdrawal by Subject             0             2             2
Protocol Violation             0             0             2
Pregnancy             0             1             1
Sponsor requested subject withdrawal             0             0             2
Lost to Follow-up             0             0             4
[1]
One participant took both placebo and albuterol so is counted in both treatment groups for safety.
Period Title: 40-Week Open-Label Period
Started 0 165 156
Completed 0 146 146
Not Completed 0 19 10
Reason Not Completed
Adverse Event             0             3             2
Withdrawal by Subject             0             11             7
Pregnancy             0             2             1
Sponsor requested subject withdrawal             0             1             0
Lost to Follow-up             0             2             0
Arm/Group Title Placebo MDPI-Albuterol MDPI Albuterol MDPI-Albuterol MDPI Total
Hide Arm/Group Description

During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

Total of all reporting groups
Overall Number of Baseline Participants 169 168 337
Hide Baseline Analysis Population Description
Full analysis set of randomized subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 169 participants 168 participants 337 participants
37.1  (15.14) 36.6  (15.04) 36.8  (15.07)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 169 participants 168 participants 337 participants
12-17 years 19 25 44
18-64 years 143 135 278
65+ years 7 8 15
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 169 participants 168 participants 337 participants
Female
111
  65.7%
103
  61.3%
214
  63.5%
Male
58
  34.3%
65
  38.7%
123
  36.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 169 participants 168 participants 337 participants
White 129 125 254
Black 35 38 73
Asian 2 4 6
American Indian or Alaskan Native 2 1 3
Pacific Islander 1 0 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 169 participants 168 participants 337 participants
Hispanic or Latino 25 28 53
Not Hispanic or Latino 144 140 284
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 169 participants 168 participants 337 participants
82.3  (21.09) 81.2  (21.4) 81.8  (21.22)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 169 participants 168 participants 337 participants
167.4  (8.67) 168.6  (9.52) 168.0  (9.11)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 169 participants 168 participants 337 participants
29.2  (6.96) 28.5  (6.81) 28.8  (6.88)
1.Primary Outcome
Title Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)
Hide Description Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time Frame Day 1 to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo MDPI-Albuterol MDPI Albuterol MDPI-Albuterol MDPI
Hide Arm/Group Description:

During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

Overall Number of Participants Analyzed 170 168
Measure Type: Number
Unit of Measure: participants
Any adverse event 105 84
Severe adverse event 6 3
Treatment-related adverse event 1 5
Deaths 0 0
Other serious adverse events 1 0
Withdrawn from treatment due to adverse events 1 1
2.Primary Outcome
Title Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)
Hide Description Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time Frame Weeks 13-52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo MDPI-Albuterol MDPI Albuterol MDPI-Albuterol MDPI
Hide Arm/Group Description:

During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

Overall Number of Participants Analyzed 165 156
Measure Type: Number
Unit of Measure: participants
Any adverse event 106 94
Severe adverse event 12 13
Treatment-related adverse event 2 1
Deaths 0 0
Other serious adverse events 3 4
Withdrawn from treatment due to adverse events 2 2
3.Primary Outcome
Title Electrocardiogram (ECG) Results At Weeks 0, 12, and 52
Hide Description A standard 12-lead ECG was performed at screening, week 12, and week 52 or early termination/discontinuation. The ECG recording methods were centralized and standardized across all study participants. A centralized cardiologist was responsible for providing all ECG interpretations.
Time Frame Weeks 0 (screening visit), 12, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Participants with assessments at each time point are reported.
Arm/Group Title Placebo MDPI-Albuterol MDPI Albuterol MDPI-Albuterol MDPI
Hide Arm/Group Description:

During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

Overall Number of Participants Analyzed 170 168
Measure Type: Number
Unit of Measure: participants
Week 0: Normal 151 154
Week 0: Abnormal, not clinically relevant 19 14
Week 0: Abnormal, clinically relevant 0 0
Week 12: Normal (n=166, 155) 143 140
Week 12: Abnormal, not clinically relevant 23 15
Week 12: Abnormal, clinically relevant 0 0
Week 52: Normal (n=152, 161) 138 148
Week 52: Abnormal, not clinically relevant 23 13
Week 52: Abnormal, clinically relevant 1 0
4.Primary Outcome
Title Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52
Hide Description

Participants were seated at least 2 minutes before blood pressure measurements were obtained by either an electronic or manual sphygmomanometer.

Week 12 values represent change from Week 0. Week 52 values represent change from Week 12.

Time Frame Week 0, Week 12 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Participants with assessments at each time point are reported.
Arm/Group Title Placebo MDPI-Albuterol MDPI Albuterol MDPI-Albuterol MDPI
Hide Arm/Group Description:

During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

Overall Number of Participants Analyzed 170 168
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic BP Week 12 (n=166, 155) 1.0  (11.27) 0.2  (10.99)
Systolic BP Week 52 (n=159, 155) -0.4  (11.54) 0.7  (10.31)
Diastolic BP Week 12 (n=166, 155) 0.0  (9.16) 0.3  (7.62)
Diastolic BP Week 52 (n=159, 155) 0.2  (9.14) 1.0  (8.15)
5.Primary Outcome
Title Change From Baseline in Pulse Measurements to Week 12 and Week 52
Hide Description

Participants were seated at least 2 minutes before pulse measurements were obtained by radial pulse.

Week 12 values represent change from Week 0. Week 52 values represent change from Week 12.

Time Frame Week 0, Week 12 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Participants with assessments at each time point are reported.
Arm/Group Title Placebo MDPI-Albuterol MDPI Albuterol MDPI-Albuterol MDPI
Hide Arm/Group Description:

During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

Overall Number of Participants Analyzed 170 168
Mean (Standard Deviation)
Unit of Measure: beats/minute
Pulse Week 12 (n=166, 155) -0.1  (9.40) 0.9  (9.53)
Pulse Week 52 (n=159, 155) -0.4  (10.08) -0.3  (9.77)
6.Primary Outcome
Title Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
Hide Description

The physical exam was performed by a qualified healthcare professional, and when possible, the same qualified healthcare professional that performed the physical examination at study screening performed all the scheduled physical examinations. Abnormalities and clinical relevance were determined by the qualified healthcare professional.

HEENT = head, eyes, ears, nose, throat

Time Frame Weeks 0, 12 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Participants with assessments at each time point are reported.
Arm/Group Title Placebo MDPI-Albuterol MDPI Albuterol MDPI-Albuterol MDPI
Hide Arm/Group Description:

During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

Overall Number of Participants Analyzed 170 168
Measure Type: Number
Unit of Measure: participants
General appearance - Week 0 (n=170, 167) 0 0
General appearance - Week 12 (n=166, 155) 1 0
General appearance - Week 52 (n=162, 161) 0 0
HEENT - Week 0 (n=170, 167) 0 0
HEENT - Week 12 (n=166, 155) 1 1
HEENT - Week 52 (n=162, 161) 2 2
Chest and lungs - Week 0 (n=170, 167) 0 0
Chest and lungs - Week 12 (n=166, 155) 1 1
Chest and lungs - Week 52 (n=162, 161) 3 2
Heart - Week 0 (n=170, 167) 0 0
Heart - Week 12 (n=166, 155) 0 0
Heart - Week 52 (n=162, 161) 0 0
Abdomen - Week 0 (n=168, 167) 0 0
Abdomen - Week 12 (n=166, 155) 0 0
Abdomen - Week 52 (n=162, 161) 0 1
Musculoskeletal - Week 0 (n=169, 167) 0 0
Musculoskeletal - Week 12 (n=166, 155) 0 0
Musculoskeletal - Week 52 (n=162, 161) 0 0
Skin - Week 0 (n=169, 167) 0 0
Skin - Week 12 (n=167, 155) 0 0
Skin - Week 52 (n=162, 161) 0 0
Lymph Nodes - Week 0 (n=169, 167) 0 0
Lymph Nodes - Week 120 (n=166, 155) 0 0
Lymph Nodes - Week 52 (n=162, 161) 0 0
Neurological - Week 0 (n=169, 167) 0 0
Neurological - Week 12 (n=166, 155) 0 0
Neurological - Week 52 (n=162, 161) 0 0
Extremities/back - Week 0 (n=169, 167) 0 0
Extremities/back - Week 12 (n=166, 155) 0 0
Extremities/back - Week 52 (n=162, 160) 0 0
7.Other Pre-specified Outcome
Title Composite Measurement of Device Ruggedness From Baseline to Week 52
Hide Description Device Ruggedness: Reports of any problems/malfunction of the device (e.g., lack of efficacy, problems/malfunction after the device is dropped or sustains physical impact).
Time Frame Baseline to Week 52
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Device Invitro Evaluations to Week 52
Hide Description

Device In Vitro Evaluations - All used study inhalers will be collected and a random selection of inhalers will be tested as follows:

  • Fifty (50) Albuterol Spiromax® inhalers used during weeks 0-12 will be randomly selected for in vitro testing
  • Fifty (50) Albuterol Spiromax® inhalers used during weeks 12-52 will be randomly selected for in vitro performance testing
Time Frame Baseline to Week 52
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Daily AM Peak Expiratory Flow (PEF) to Week 52
Hide Description Daily AM PEF will be recorded throughout the duration of the study to provide information on the subject's asthma status in order to assist in distinguishing between the use of back-up rescue medication related to an increased need for asthma symptom relief from that related to an issue with the Albuterol Spiromax® rescue inhaler.
Time Frame Baseline to Week 52
Outcome Measure Data Not Reported
Time Frame Day 1 to Week 52
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albuterol MDPI - Double-blind Period Placebo MDPI - Double-blind Period Albuterol MDPI (Formerly Placebo) - Open Label Period Albuterol MDPI (Formerly Albuterol) - Open Label Period
Hide Arm/Group Description Albuterol multi-dose dry powder inhaler (MDPI or Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Placebo delivered using a multi-dose dry powder inhaler (MDPI or Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. After completing 12 weeks of placebo QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN). After completing 12 weeks of albuterol QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
All-Cause Mortality
Albuterol MDPI - Double-blind Period Placebo MDPI - Double-blind Period Albuterol MDPI (Formerly Placebo) - Open Label Period Albuterol MDPI (Formerly Albuterol) - Open Label Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol MDPI - Double-blind Period Placebo MDPI - Double-blind Period Albuterol MDPI (Formerly Placebo) - Open Label Period Albuterol MDPI (Formerly Albuterol) - Open Label Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/168 (0.00%)      1/170 (0.59%)      3/169 (1.78%)      4/168 (2.38%)    
Cardiac disorders         
Atrial fibrillation  1  0/168 (0.00%)  0 0/170 (0.00%)  0 0/169 (0.00%)  0 1/168 (0.60%)  1
Infections and infestations         
Cellulitis  1  0/168 (0.00%)  0 0/170 (0.00%)  0 0/169 (0.00%)  0 1/168 (0.60%)  1
Musculoskeletal and connective tissue disorders         
Flank pain  1  0/168 (0.00%)  0 0/170 (0.00%)  0 1/169 (0.59%)  1 0/168 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Gastrointestinal carcinoma  1  0/168 (0.00%)  0 0/170 (0.00%)  0 0/169 (0.00%)  0 1/168 (0.60%)  1
Pancreatic carcinoma  1  0/168 (0.00%)  0 0/170 (0.00%)  0 0/169 (0.00%)  0 1/168 (0.60%)  1
Papillary thyroid cancer  1  0/168 (0.00%)  0 0/170 (0.00%)  0 1/169 (0.59%)  1 0/168 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1  0/168 (0.00%)  0 1/170 (0.59%)  1 0/169 (0.00%)  0 0/168 (0.00%)  0
Renal and urinary disorders         
Nephrolithiasis  1  0/168 (0.00%)  0 0/170 (0.00%)  0 1/169 (0.59%)  1 0/168 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/168 (0.00%)  0 0/170 (0.00%)  0 1/169 (0.59%)  1 0/168 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Albuterol MDPI - Double-blind Period Placebo MDPI - Double-blind Period Albuterol MDPI (Formerly Placebo) - Open Label Period Albuterol MDPI (Formerly Albuterol) - Open Label Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/168 (30.36%)      80/170 (47.06%)      64/169 (37.87%)      67/168 (39.88%)    
Infections and infestations         
Bronchitis  1  3/168 (1.79%)  4 9/170 (5.29%)  10 6/169 (3.55%)  7 6/168 (3.57%)  6
Influenza  1  3/168 (1.79%)  3 10/170 (5.88%)  11 1/169 (0.59%)  1 2/168 (1.19%)  2
Nasopharyngitis  1  10/168 (5.95%)  12 17/170 (10.00%)  22 16/169 (9.47%)  20 20/168 (11.90%)  26
Sinusitis  1  8/168 (4.76%)  9 13/170 (7.65%)  14 10/169 (5.92%)  11 19/168 (11.31%)  23
Upper respiratory tract infection  1  23/168 (13.69%)  26 31/170 (18.24%)  36 27/169 (15.98%)  36 15/168 (8.93%)  16
Nervous system disorders         
Headache  1  10/168 (5.95%)  19 12/170 (7.06%)  16 8/169 (4.73%)  25 10/168 (5.95%)  18
Respiratory, thoracic and mediastinal disorders         
Cough  1  7/168 (4.17%)  8 12/170 (7.06%)  13 18/169 (10.65%)  19 11/168 (6.55%)  14
Oropharyngeal pain  1  7/168 (4.17%)  7 11/170 (6.47%)  11 10/169 (5.92%)  12 10/168 (5.95%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor’s review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor’s designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 1-215-591-3000
EMail: ustevatrials@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01698320     History of Changes
Other Study ID Numbers: ABS-AS-307
First Submitted: September 14, 2012
First Posted: October 3, 2012
Results First Submitted: July 13, 2015
Results First Posted: August 19, 2015
Last Update Posted: August 19, 2015