A Phase 2 interventional study of TC-6987 and Placebo in Asthma, sponsored by Targacept Inc.. Completed at 21 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-13.
Sponsored by Targacept Inc. · Phase 2, Interventional, and Treatment
This study is designed to determine whether TC-6987 improves respiratory function in subjects with asthma by reducing airway hyper-responsiveness and inflammation.
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.
4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 203 is above the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Targacept Inc. is the lead sponsor of 16 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: TC-6987
Drug: Placebo
TC-6987 50 mg capsule given once daily on Days 1 to 28
Matching placebo capsule given once daily on Days 1 to 28
Change in FEV1 status on Day 28 compared to baseline as a function of treatment (TC-6987 versus placebo)
Co-primary efficacy endpoints: 1. the change in FEV1 from pre dose on Day 1 to pre dose on Day 28 2. the change in FEV1 from pre dose on Day 1 to 2 h post dose on Day 28
Time frame: Day 28
Number of Asthma Control Days
Number of Asthma Control Days from 14 days prior to Day 1, compared to the 14 days prior to Day 28, as a function of Treatment
Time frame: Day 1
Decrease in FEV1 after methacholine dose as a function of treatment
Percentage of patients in which methacholine dose decreases FEV1 by 20% (PC20) at Day 29 compared to Day -1
Time frame: Day 29
Number of Asthma Control Days
Number of Asthma Control Days from 14 days prior to Day 1, compared to the 14 days prior to Day 28, as a function of Treatment
Time frame: Day 28
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Targacept Inc.