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

Overview

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

  • 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

Interventions

  • 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

Primary 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

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)

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Theravance Biopharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Glenn Crater, Study Director, Theravance Biopharma, US, Inc.

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