NCT01296087

TC-6987 for the Treatment of Mild to Moderate Asthma

A Phase II Multicenter, Randomized, Double-Blind,Parallel Group, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetic Parameters of TC-6987 in Subjects With Persistent Mild to Moderate Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Targacept Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is designed to determine whether TC-6987 improves respiratory function in subjects with asthma by reducing airway hyper-responsiveness and inflammation.

Detailed description

Asthma is a common, chronic inflammatory disorder of the airways that affects an estimated 20 to 22 million people in the United States. It is characterized by variable and recurring symptoms, notably airflow obstruction, bronchial hyperresponsiveness, and an underlying inflammation. The bronchospasm is caused by inflammation of the muscles surrounding the air passageways, making them smaller, thus more difficult for air to freely move in and out of the lungs. Cardinal symptoms of asthma include coughing, chest tightness, shortness of breath and wheezing. These symptoms are often more severe in the morning and late night, and usually reversible with medications. Clinically, asthma is typically classified according to the frequency of symptoms, forced expiratory volume in 1 second (FEV1), and peak expiratory flow rate. The rationale for this Phase II proof of concept study is to demonstrate that TC-6987 improves respiratory function in subjects with asthma, compared to placebo, as measured by the Baseline FEV1 on Day 1 compared to the End-of-Treatment FEV1 on Day 28 or Early Withdrawal (EW); and also to assess the safety and tolerability profile of TC-6987 in subjects with asthma.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	TC-6987	TC-6987 50 mg capsule given once daily on Days 1 to 28
DRUG	Placebo	Matching placebo capsule given once daily on Days 1 to 28

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-02-15
• Last updated: 2013-09-13

Locations

21 sites across 1 country: United States