A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product when administered once daily for 28 days using a jet nebulizer to patients with moderate to severe chronic obstructive pulmonary disease.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02109172

Chronic Obstructive Pulmonary Disease COPD

COMPLETED PHASE2

Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)

NCT02459080

Chronic Obstructive Pulmonary Disease (COPD)

COMPLETED PHASE3

Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)

NCT02512510

Chronic Obstructive Pulmonary Disease (COPD)

COMPLETED PHASE3

7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

NCT01704404

COPD

COMPLETED PHASE2

Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT03064113

Chronic Obstructive Pulmonary Disease, COPD

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

44 mcg

TD-4208

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

88 mcg

TD-4208

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

175 mcg

TD-4208

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

350 mcg

TD-4208

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TD-4208

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

revefenacin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject is a male or female subject 40 years of age or older
* 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 ratio \<0.7
* Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)
* Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
* 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 or nebulized 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)

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No