Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Cross-Over Study of QD and BID Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
NCT number | NCT02109172 |
Other study ID # | 0116 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | October 2014 |
Verified date | February 2022 |
Source | Viatris Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design to patients with moderate to severe chronic obstructive pulmonary disease.
Status | Completed |
Enrollment | 64 |
Est. completion date | October 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - 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 (forced expiratory volume in 1 second/forced vital capacity) ratio <0.7 - Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the Global Initiative for the Treatment of Obstructive Lung Disease (GOLD) Guidelines) - Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal - Subject demonstrates a post-ipratropium FEV1 response = 12% and = 200 mL of pre-ipratropium FEV1 response - 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 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) |
Country | Name | City | State |
---|---|---|---|
United States | American Health Research | Charlotte | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Mylan Inc. | Theravance Biopharma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second) | Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline. | Following the Day 7 AM dose -12 hours post-dose and 24 hours post-dose |
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