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

NCT02109172 | Completed Phase 2 Results

• 1 other identifier: 0116
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Keywords

Chronic Obstructive Pulmonary Disease; COPD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

TD-4208 44 mcg twice daily

EXPERIMENTAL

TD-4208 inhalation solution 44 mcg twice daily for 7 days

Drug: TD-4208

Placebo

PLACEBO COMPARATOR

Placebo inhalation solution twice daily for 7 days

Drug: Placebo

TD-4208 175 mcg once daily

EXPERIMENTAL

TD-4208 inhalation solution 175 mcg once daily, placebo once daily

Drug: TD-4208; Drug: Placebo

Interventions

TD-4208 DRUG

Also known as: Revefenacin

TD-4208 175 mcg once daily; TD-4208 44 mcg twice daily

Placebo DRUG

Placebo; TD-4208 175 mcg once daily

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mylan Inc.: lead
• Theravance Biopharma: collaborator

Study Sites (1)

American Health Research

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

revefenacin

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study was designed to evaluate whether a lower dose (44) BID would achieve a greater response than a higher dose (175) QD.

Results Point of Contact

• Title: Head of Clinical Development & Medical Affairs
• Organization: Theravance Biopharma

medinfo@theravance.com

1-855-633-8479

Study Officials

• Medical Monitor

  Theravance Biopharma, US, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2014
• First Posted: April 9, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 24, 2022
• Results First Posted: December 8, 2016

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)