COPD
Conditions
Keywords
COPD, Chronic Obstructive Pulmonary Disease
Brief summary
This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product when administered once daily for 28 days using a jet nebulizer to patients with moderate to severe chronic obstructive pulmonary disease.
Interventions
DRUGTD-4208
DRUGPlacebo
Sponsors
Theravance Biopharma
Mylan Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is a male or female subject 40 years of age or older * Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential * Subject is capable of performing reproducible spirometry maneuvers * Subject has post-bronchodilator FEV1/FVC ratio \<0.7 * Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines) * Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal * Subject has a current or past smoking history of at least 10 pack-years.
Exclusion criteria
* Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study * Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents * Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents * Subject has been hospitalized for COPD or pneumonia within 12 weeks * Subject requires long-term oxygen therapy (\>15 hours a day)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second) | Baseline to 28 days |
Countries
United States
Participant flow
Pre-assignment details
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK (GlaxoSmithKline) study with another investigational agent at the same time as their participation in this study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo
Placebo | 70 |
| 44 mcg TD-4208
TD-4208 | 68 |
| 88 mcg TD-4208
TD-4208 | 71 |
| 175 mcg TD-4208
TD-4208 | 71 |
| 350 mcg TD-4208
TD-4208 | 74 |
| Total | 354 |
Baseline characteristics
| Characteristic | Placebo | 44 mcg | 88 mcg | 175 mcg | 350 mcg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 62.2 years STANDARD_DEVIATION 9.17 | 60.9 years STANDARD_DEVIATION 8.87 | 60.4 years STANDARD_DEVIATION 7.98 | 64.5 years STANDARD_DEVIATION 7.69 | 61.4 years STANDARD_DEVIATION 8.98 | 61.9 years STANDARD_DEVIATION 8.63 |
| Sex: Female, Male Female | 33 Participants | 36 Participants | 39 Participants | 34 Participants | 34 Participants | 176 Participants |
| Sex: Female, Male Male | 37 Participants | 32 Participants | 32 Participants | 37 Participants | 40 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 71 | 1 / 68 | 6 / 71 | 10 / 71 | 15 / 74 |
| serious Total, serious adverse events | 0 / 71 | 1 / 68 | 0 / 71 | 2 / 71 | 1 / 74 |
Outcome results
Primary
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)
Time frame: Baseline to 28 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second) | -32.4 mL | Standard Error 25.36 |
| 44 mcg | Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second) | 19.4 mL | Standard Error 24.98 |
| 88 mcg | Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second) | 155.0 mL | Standard Error 24.61 |
| 175 mcg | Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second) | 134.2 mL | Standard Error 25.07 |
| 350 mcg | Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second) | 138.2 mL | Standard Error 24.38 |