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Completed

NCT Number: NCT02109172

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

American Health Research

Charlotte, North Carolina, 28207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TD-4208

Drug

Other names: Revefenacin

Placebo

Drug

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Collaborators

  • Theravance Biopharma

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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