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.
Full Title of Study: “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”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: September 2014
- Drug: TD-4208
- Drug: Placebo
Arms, Groups and Cohorts
- Experimental: TD-4208 44 mcg twice daily
- TD-4208 inhalation solution 44 mcg twice daily for 7 days
- Placebo Comparator: Placebo
- Placebo inhalation solution twice daily for 7 days
- Experimental: TD-4208 175 mcg once daily
- TD-4208 inhalation solution 175 mcg once daily, placebo once daily
Clinical Trial Outcome Measures
- Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second)
- Time Frame: Following the Day 7 AM dose -12 hours post-dose and 24 hours post-dose
- Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline.
Participating in This Clinical Trial
- 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.
- 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)
Gender Eligibility: All
Minimum Age: 40 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Theravance Biopharma
- Provider of Information About this Clinical Study
- Overall Official(s)
- Glenn Crater, Study Director, Theravance Biopharma, US, Inc.
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