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

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ClinicalTrials.gov Identifier: NCT02512510
Recruitment Status : Completed
First Posted : July 31, 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 611
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 205 197 209
Completed 163 162 157
Not Completed 42 35 52
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 205 197 208 610
Hide Baseline Analysis Population Description
611 subjects randomized. 1 subject was not dosed and was thus not included in any analyses.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 205 participants 197 participants 208 participants 610 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
121
  59.0%
106
  53.8%
115
  55.3%
342
  56.1%
>=65 years
84
  41.0%
91
  46.2%
93
  44.7%
268
  43.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 205 participants 197 participants 208 participants 610 participants
63.1  (8.81) 63.6  (9.19) 63.5  (8.91) 63.4  (8.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 205 participants 197 participants 208 participants 610 participants
Female
102
  49.8%
95
  48.2%
111
  53.4%
308
  50.5%
Male
103
  50.2%
102
  51.8%
97
  46.6%
302
  49.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 205 participants 197 participants 208 participants 610 participants
Hispanic or Latino
17
   8.3%
10
   5.1%
12
   5.8%
39
   6.4%
Not Hispanic or Latino
188
  91.7%
186
  94.4%
194
  93.3%
568
  93.1%
Unknown or Not Reported
0
   0.0%
1
   0.5%
2
   1.0%
3
   0.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 205 participants 197 participants 208 participants 610 participants
American Indian or Alaska Native
0
   0.0%
1
   0.5%
0
   0.0%
1
   0.2%
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
17
   8.3%
21
  10.7%
20
   9.6%
58
   9.5%
White
186
  90.7%
171
  86.8%
188
  90.4%
545
  89.3%
More than one race
1
   0.5%
2
   1.0%
0
   0.0%
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 205 participants 197 participants 208 participants 610 participants
205 197 208 610
Smoking Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 205 participants 197 participants 208 participants 610 participants
Current Smoker
97
  47.3%
94
  47.7%
95
  45.7%
286
  46.9%
Former Smoker
108
  52.7%
103
  52.3%
113
  54.3%
324
  53.1%
1.Primary Outcome
Title Change From Baseline in Trough FEV1 on Day 85
Hide Description [Not Specified]
Time Frame Baseline and 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 152 154 150
Least Squares Mean (Standard Error)
Unit of Measure: mL
115.58  (18.637) 102.90  (18.542) -44.92  (18.841)
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 189 181 187
Mean (Standard Error)
Unit of Measure: mL
83.9  (3.14) 87.1  (3.21) -39.9  (3.15)
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 204 196 208
Least Squares Mean (Standard Error)
Unit of Measure: mL
218.65  (10.291) 216.84  (10.248) 88.22  (10.092)
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 202 196 203
Least Squares Mean (Standard Error)
Unit of Measure: Puffs per Day
2.00  (0.207) 2.38  (0.204) 2.54  (0.206)
5.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 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 145 149 140
Measure Type: Count of Participants
Unit of Measure: Participants
67
  46.2%
67
  45.0%
54
  38.6%
6.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 205 197 207
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of 24hr periods
44.79  (2.800) 43.26  (2.769) 37.23  (2.766)
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   0/205 (0.00%)      1/197 (0.51%)      0/209 (0.00%)    
Hide Serious Adverse Events
TD-4208-1 TD-4208-2 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/205 (5.37%)      5/197 (2.54%)      7/209 (3.35%)    
Gastrointestinal disorders       
Small intestinal obstruction  2  1/205 (0.49%)  1 0/197 (0.00%)  0 0/209 (0.00%)  0
General disorders       
Chest pain  2  1/205 (0.49%)  1 0/197 (0.00%)  0 0/209 (0.00%)  0
Infections and infestations       
Cellulitis  2  1/205 (0.49%)  1 0/197 (0.00%)  0 1/209 (0.48%)  1
Bronchitis  2  0/205 (0.00%)  0 1/197 (0.51%)  1 0/209 (0.00%)  0
Bronchitis bacterial  2  1/205 (0.49%)  1 0/197 (0.00%)  0 0/209 (0.00%)  0
Pneumonia  2  0/205 (0.00%)  0 1/197 (0.51%)  1 0/209 (0.00%)  0
Metabolism and nutrition disorders       
Lactic acidosis  2  1/205 (0.49%)  1 0/197 (0.00%)  0 0/209 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Bursitis  1  0/205 (0.00%)  0 0/197 (0.00%)  0 1/209 (0.48%)  1
Musculoskeletal Chest Pain  2  0/205 (0.00%)  0 1/197 (0.51%)  1 0/209 (0.00%)  0
Nervous system disorders       
Cerebrolvascular Accident  2  0/205 (0.00%)  0 0/197 (0.00%)  0 1/209 (0.48%)  1
Spondylitic myelopathy  2  0/205 (0.00%)  0 0/197 (0.00%)  0 1/209 (0.48%)  1
Psychiatric disorders       
Bipolar disorder  2  0/205 (0.00%)  0 1/197 (0.51%)  1 0/209 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  8/205 (3.90%)  8 1/197 (0.51%)  1 4/209 (1.91%)  4
Acute respiratory failure  2  2/205 (0.98%)  2 0/197 (0.00%)  0 0/209 (0.00%)  0
Respiratory Failure  1  1/205 (0.49%)  1 0/197 (0.00%)  0 0/209 (0.00%)  0
Social circumstances       
Victim of homicide  2  0/205 (0.00%)  0 1/197 (0.51%)  1 0/209 (0.00%)  0
1
Term from vocabulary, MedDRA (18.1)
2
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   59/205 (28.78%)      62/197 (31.47%)      52/209 (24.88%)    
Infections and infestations       
Upper respiratory tract infection  1  6/205 (2.93%)  6 10/197 (5.08%)  10 5/209 (2.39%)  5
Nasopharyngitis  1  7/205 (3.41%)  7 9/197 (4.57%)  9 4/209 (1.91%)  4
Musculoskeletal and connective tissue disorders       
Back Pain  2  4/205 (1.95%)  4 7/197 (3.55%)  7 3/209 (1.44%)  3
Nervous system disorders       
Headache  1  14/205 (6.83%)  14 8/197 (4.06%)  8 6/209 (2.87%)  6
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  25/205 (12.20%)  25 21/197 (10.66%)  21 25/209 (11.96%)  25
Cough  1  9/205 (4.39%)  9 10/197 (5.08%)  10 9/209 (4.31%)  9
Dyspnoea  1  6/205 (2.93%)  6 8/197 (4.06%)  8 12/209 (5.74%)  12
1
Term from vocabulary, MedDRA 18.1
2
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: NCT02512510    
Other Study ID Numbers: 0127
First Submitted: July 28, 2015
First Posted: July 31, 2015
Results First Submitted: December 6, 2018
Results First Posted: December 31, 2018
Last Update Posted: May 7, 2021