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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109172
• Other study ID #: 0116
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: February 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• TD-4208

• Placebo

Locations

Country	Name	City	State
United States	American Health Research	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

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