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Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) (COPD)

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ClinicalTrials.gov Identifier: NCT02459080
Recruitment Status : Completed
First Posted : June 1, 2015
Results First Posted : December 31, 2018
Last Update Posted : May 7, 2021
Sponsor:
Collaborator:
Theravance Biopharma
Information provided by (Responsible Party):
Mylan Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: TD-4208
Drug: Placebo
Enrollment 619
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TD-4208-1 TD-4208-2 Placebo
Hide Arm/Group Description

88 mcg

TD-4208

175 mcg

TD-4208

Placebo

Placebo

Period Title: Overall Study
Started 212 198 209
Completed 168 158 151
Not Completed 44 40 58
Arm/Group Title TD-4208-1 TD-4208-2 Placebo Total
Hide Arm/Group Description

88 mcg

TD-4208

175 mcg

TD-4208

Placebo

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 212 198 209 619
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 198 participants 209 participants 619 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
112
  52.8%
96
  48.5%
104
  49.8%
312
  50.4%
>=65 years
100
  47.2%
102
  51.5%
105
  50.2%
307
  49.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 212 participants 198 participants 209 participants 619 participants
63.7  (8.90) 64.2  (8.60) 64.3  (9.12) 64.1  (8.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 198 participants 209 participants 619 participants
Female
97
  45.8%
105
  53.0%
100
  47.8%
302
  48.8%
Male
115
  54.2%
93
  47.0%
109
  52.2%
317
  51.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 198 participants 209 participants 619 participants
Hispanic or Latino
4
   1.9%
6
   3.0%
3
   1.4%
13
   2.1%
Not Hispanic or Latino
205
  96.7%
186
  93.9%
204
  97.6%
595
  96.1%
Unknown or Not Reported
3
   1.4%
6
   3.0%
2
   1.0%
11
   1.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 198 participants 209 participants 619 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.5%
2
   1.0%
0
   0.0%
3
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
16
   7.5%
16
   8.1%
17
   8.1%
49
   7.9%
White
194
  91.5%
179
  90.4%
191
  91.4%
564
  91.1%
More than one race
1
   0.5%
1
   0.5%
1
   0.5%
3
   0.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 212 participants 198 participants 209 participants 619 participants
212 198 209 619
Smoking Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 198 participants 209 participants 619 participants
Current Smoker
102
  48.1%
96
  48.5%
103
  49.3%
301
  48.6%
Former Smoker
110
  51.9%
102
  51.5%
106
  50.7%
318
  51.4%
1.Primary Outcome
Title Change From Baseline in Trough FEV1 on Day 85
Hide Description [Not Specified]
Time Frame Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set
Arm/Group Title TD-4208-1 TD-4208-2 Placebo
Hide Arm/Group Description:

88 mcg

TD-4208

175 mcg

TD-4208

Placebo

Placebo

Overall Number of Participants Analyzed 161 156 146
Least Squares Mean (Standard Error)
Unit of Measure: mL
59.81  (15.095) 126.85  (15.389) -19.41  (16.108)
2.Secondary Outcome
Title Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85
Hide Description [Not Specified]
Time Frame Days 15 to 85
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TD-4208-1 TD-4208-2 Placebo
Hide Arm/Group Description:

88 mcg

TD-4208

175 mcg

TD-4208

Placebo

Placebo

Overall Number of Participants Analyzed 201 189 191
Mean (Standard Error)
Unit of Measure: mL
73.0  (3.10) 124.8  (3.20) -30.8  (3.18)
3.Secondary Outcome
Title Summary of Change From Baseline to Peak FEV1 After First Dose
Hide Description [Not Specified]
Time Frame 0-2 hours after First Dose Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TD-4208-1 TD-4208-2 Placebo
Hide Arm/Group Description:

88 mcg

TD-4208

175 mcg

TD-4208

Placebo

Placebo

Overall Number of Participants Analyzed 212 198 208
Least Squares Mean (Standard Error)
Unit of Measure: mL
218.14  (9.546) 224.46  (9.744) 91.79  (9.963)
4.Secondary Outcome
Title Summary of Rescue Medication Use: Puffs Per Day
Hide Description [Not Specified]
Time Frame 1-3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TD-4208-1 TD-4208-2 Placebo
Hide Arm/Group Description:

88 mcg

TD-4208

175 mcg

TD-4208

Placebo

Placebo

Overall Number of Participants Analyzed 212 197 206
Least Squares Mean (Standard Error)
Unit of Measure: Puffs per Day
2.26  (0.234) 2.27  (0.239) 2.72  (0.246)
5.Secondary Outcome
Title Percentage of Albuterol Rescue-free 24-hour Periods
Hide Description [Not Specified]
Time Frame 1-3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TD-4208-1 TD-4208-2 Placebo
Hide Arm/Group Description:

88 mcg

TD-4208

175 mcg

TD-4208

Placebo

Placebo

Overall Number of Participants Analyzed 211 197 209
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of 24 hr periods
48.35  (2.784) 43.57  (2.829) 45.21  (2.890)
6.Secondary Outcome
Title St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85
Hide Description A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units
Time Frame Baseline to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TD-4208-1 TD-4208-2 Placebo
Hide Arm/Group Description:

88 mcg

TD-4208

175 mcg

TD-4208

Placebo

Placebo

Overall Number of Participants Analyzed 148 139 136
Measure Type: Count of Participants
Unit of Measure: Participants
70
  47.3%
68
  48.9%
46
  33.8%
Time Frame From signing of ICF through the final follow-up assessment, Day 85.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TD-4208-1 TD-4208-2 Placebo
Hide Arm/Group Description

88 mcg

TD-4208

175 mcg

TD-4208

Placebo

Placebo

All-Cause Mortality
TD-4208-1 TD-4208-2 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/212 (0.00%)      0/198 (0.00%)      1/209 (0.48%)    
Hide Serious Adverse Events
TD-4208-1 TD-4208-2 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/212 (4.72%)      10/198 (5.05%)      14/209 (6.70%)    
Cardiac disorders       
Acute myocardial infarction  1  1/212 (0.47%)  1 1/198 (0.51%)  1 0/209 (0.00%)  0
Atrial fibrillation  1  1/212 (0.47%)  1 0/198 (0.00%)  0 0/209 (0.00%)  0
Congestive cardiomyopathy  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
Silent myocardial infarction  1  1/212 (0.47%)  1 0/198 (0.00%)  0 0/209 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
Gastrointestinal disorders       
Upper gastrointestinal haemorrhage  1  1/212 (0.47%)  1 1/198 (0.51%)  1 0/209 (0.00%)  0
Abdominal discomfort  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
Gastric volvulus  1  1/212 (0.47%)  1 0/198 (0.00%)  0 0/209 (0.00%)  0
Ileus  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
General disorders       
Chest pain  1  1/212 (0.47%)  1 1/198 (0.51%)  1 0/209 (0.00%)  0
Non-cardiac chest pain  1  0/212 (0.00%)  0 1/198 (0.51%)  1 1/209 (0.48%)  1
Chest discomfort  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
Death  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
Infections and infestations       
Cellulitis  1  1/212 (0.47%)  1 0/198 (0.00%)  0 0/209 (0.00%)  0
Pneumonia parainfluenzae viral  1  0/212 (0.00%)  0 1/198 (0.51%)  1 0/209 (0.00%)  0
Injury, poisoning and procedural complications       
Femur fracture  1  1/212 (0.47%)  1 0/198 (0.00%)  0 0/209 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Musculoskeletal pain  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
Rheumatoid arthritis  1  1/212 (0.47%)  1 0/198 (0.00%)  0 0/209 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer  1  0/212 (0.00%)  0 1/198 (0.51%)  1 0/209 (0.00%)  0
Invasive ductal breast carcinoma  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
Lung adenocarcinoma  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
Squamous cell carcinoma  1  0/212 (0.00%)  0 1/198 (0.51%)  1 0/209 (0.00%)  0
Nervous system disorders       
Dizziness  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
Migraine  1  0/212 (0.00%)  0 1/198 (0.51%)  1 0/209 (0.00%)  0
Transient ischaemic attack  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
Psychiatric disorders       
Panic attack  1  1/212 (0.47%)  1 0/198 (0.00%)  0 0/209 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/212 (0.00%)  0 4/198 (2.02%)  4 2/209 (0.96%)  2
Bronchiectasis  1  0/212 (0.00%)  0 1/198 (0.51%)  1 0/209 (0.00%)  0
Dyspnoea  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
Hypoxia  1  0/212 (0.00%)  0 1/198 (0.51%)  1 0/209 (0.00%)  0
Pneumothorax spontaneous  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
Respiratory failure  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
Vascular disorders       
Superior vena cava syndrome  1  0/212 (0.00%)  0 0/198 (0.00%)  0 1/209 (0.48%)  1
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
TD-4208-1 TD-4208-2 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/212 (24.06%)      46/198 (23.23%)      51/209 (24.40%)    
Infections and infestations       
Upper respiratory tract infection  1  14/212 (6.60%)  14 1/198 (0.51%)  1 4/209 (1.91%)  4
Nasopharyngitis  1  7/212 (3.30%)  7 6/198 (3.03%)  6 5/209 (2.39%)  5
Sinusitis  1  3/212 (1.42%)  3 5/198 (2.53%)  5 6/209 (2.87%)  6
Nervous system disorders       
Headache  1  7/212 (3.30%)  7 8/198 (4.04%)  8 5/209 (2.39%)  5
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease  1  17/212 (8.02%)  17 21/198 (10.61%)  21 23/209 (11.00%)  23
Cough  1  8/212 (3.77%)  8 7/198 (3.54%)  7 8/209 (3.83%)  8
Dyspnoea  1  7/212 (3.30%)  7 4/198 (2.02%)  4 11/209 (5.26%)  11
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by 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.
The PI may communicate the trial results generated by the PI, but only after the first publication or presentation of the combined study results generated by all participating sites. The Sponsor can then review trial results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The Sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Clinical Development & Medical Affairs
Organization: Theravance Biopharma
Phone: 1-855-633-8479
EMail: medinfo@theravance.com
Layout table for additonal information
Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT02459080    
Other Study ID Numbers: 0126
First Submitted: May 22, 2015
First Posted: June 1, 2015
Results First Submitted: December 6, 2018
Results First Posted: December 31, 2018
Last Update Posted: May 7, 2021