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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; COPD
• Interventions: Drug: TD-4208; Drug: Placebo

• Registration Number: NCT02109172
• Lead Sponsor: Mylan Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-06
• Study First Submitted QC: 2014-04-06
• Study First Posted: 2014-04-09
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Results First Submitted: 2016-10-13
• Results First Submitted QC: 2016-10-13
• Results First Posted: 2016-12-08
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TD-4208 44 mcg twice daily	TD-4208	TD-4208 inhalation solution 44 mcg twice daily for 7 days
TD-4208 175 mcg once daily	TD-4208	TD-4208 inhalation solution 175 mcg once daily, placebo once daily
Placebo	Placebo	Placebo inhalation solution twice daily for 7 days
TD-4208 175 mcg once daily	Placebo	TD-4208 inhalation solution 175 mcg once daily, placebo once daily

Primary Outcome Measures

Name	Time	Method
Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second)	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.

Trial Locations

Locations (1)

American Health Research; 🇺🇸 Charlotte, North Carolina, United States