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TC-6987 for the Treatment of Mild to Moderate Asthma

NCT ID: NCT01296087

Last Updated: 2013-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-01-31

Brief Summary

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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

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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

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Asthma

Keywords

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Asthma Mild to Moderate Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TC-6987

Group Type EXPERIMENTAL

TC-6987

Intervention Type DRUG

TC-6987 50 mg capsule given once daily on Days 1 to 28

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo capsule given once daily on Days 1 to 28

Interventions

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TC-6987

TC-6987 50 mg capsule given once daily on Days 1 to 28

Intervention Type DRUG

Placebo

Matching placebo capsule given once daily on Days 1 to 28

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. A clinical diagnosis of persistent mild to moderate asthma requiring at least 3 months of daily treatment with inhaled corticosteroids (ICS).
2. A FEV1 value at Screening that is 60-90% of predicted FEV1.
3. Age 18 to 65, males or females.

Exclusion Criteria

1. Diagnosis or presence of other pulmonary diseases including chronic obstructive pulmonary disease (COPD) and emphysema.
2. Previous life-threatening asthma, such as asthma requiring intubation or ICU admission for asthma.
3. Prolonged hospitalization for asthma within the past year (emergency room treatments using nebulized beta-agonists is permitted).
4. Not able and willing to stop the use of long-acting beta-agonists (LABAs), cromolyn sodium, methylxanthines, anticholinergic agents, leukotriene inhibitors, or any other non-ICS or non-SABA prescription or over-the-counter anti-asthma medication, including antihistamines, during Screening and during the Study.
5. Use of moderate to strong cytochrome P450 3A4 (CYP3A4) inhibitors.
6. Use of oral steroids within the last 1 month, or use of \>/= 3 steroid bursts in the last 12 months.
7. History of upper respiratory tract infection (URI) requiring treatment during the last month prior to Screening.
8. Tobacco use within 3 months prior to Screening, or \> 5 pack-year lifetime tobacco use.
9. Use of smoking cessation therapy within 3 months prior to Screening.
10. Uncontrolled Gastroesophageal reflux disease (GERD). Subjects on a stable dose of non-prescription or prescription medications who have been symptom free for 4 wks prior to screening are eligible.
11. History within past 6 months of alcohol abuse or illicit drug abuse.
12. Myocardial infarction within 12 months prior to Screening.
13. Known hypothyroidism, vitamin B12, or folic acid deficiency.
14. Known systemic infection (HBV, HCV, HIV, TB).
15. FSH level of \< 35 IU/L and a LH level \< 25 IU/L.
16. Urine cotinine level \> 50 ng/ml.
17. Body Mass Index (BMI) \<15 and \>35.
18. Participation in another clinical trial in the past 3 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Targacept Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Winder, MD

Role: PRINCIPAL_INVESTIGATOR

Toledo Center for Clinical Research

Locations

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Clinical research Center of Alabama

Birmingham, Alabama, United States

Site Status

Medical Research of Arizona

Scottsdale, Arizona, United States

Site Status

California Allergy and Asthma Medical Group, Inc.

Los Angeles, California, United States

Site Status

California Allergy & Asthma Medical Group

Palmdale, California, United States

Site Status

Waterbury Pulmonary Associates

Waterbury, Connecticut, United States

Site Status

Avail Clinical Research LLC

DeLand, Florida, United States

Site Status

Sarasota Clinical Research

Sarasota, Florida, United States

Site Status

Florida Pulmonary Research Institute, Inc.

Winter Park, Florida, United States

Site Status

Allergy Partners of Western North Carolina

Asheville, North Carolina, United States

Site Status

Toledo Center for Clinical Research

Sylvania, Ohio, United States

Site Status

Allergy & Asthma Clinical Research Center

Oklahoma City, Oklahoma, United States

Site Status

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, United States

Site Status

Altoona Lung Specialists

Altoona, Pennsylvania, United States

Site Status

Allergy & Asthma Research of New Jersey, Inc.

Philadelphia, Pennsylvania, United States

Site Status

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Site Status

Pioneer Research Solutions

Houston, Texas, United States

Site Status

Paragon Research

San Antonio, Texas, United States

Site Status

Utah Clinical Trials, LLC

Salt Lake City, Utah, United States

Site Status

VA Adult & Pediatric Allergy & Asthma PC

Richmond, Virginia, United States

Site Status

Pulmornary Consultants, PLLC

Tacoma, Washington, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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TC-6987-23-CRD-001

Identifier Type: -

Identifier Source: org_study_id