A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) 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.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TD-4208 44 mcg twice daily

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

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

Placebo

Placebo inhalation solution twice daily for 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

TD-4208 175 mcg once daily

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

Group Type EXPERIMENTAL

TD-4208

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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TD-4208

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Revefenacin

Eligibility Criteria

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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)

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No