A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COPD, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: TD-4208
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-4208 44 mcg twice daily<br>TD-4208 inhalation solution 44 mcg twice daily for 7 days | Drug: TD-4208<br> <br> * Other names: Revefenacin;|
| Placebo Comparator: Placebo<br>Placebo inhalation solution twice daily for 7 days | Drug: Placebo<br> <br> |
| Experimental: TD-4208 175 mcg once daily<br>TD-4208 inhalation solution 175 mcg once daily, placebo once daily | Drug: TD-4208<br> <br> * Other names: Revefenacin;Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, COPD