TC-6987 for the Treatment of Mild to Moderate Asthma

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT01296087

Run by

Targacept Inc.

People needed

203

Starts

2011-02-01

Expected to finish

2012-01-01

Last updated by the study team

2013-09-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Diagnosis or presence of other pulmonary diseases including chronic obstructive pulmonary disease (COPD) and emphysema.
• Previous life-threatening asthma, such as asthma requiring intubation or ICU admission for asthma.
• Prolonged hospitalization for asthma within the past year (emergency room treatments using nebulized beta-agonists is permitted).
• 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.
• Use of moderate to strong cytochrome P450 3A4 (CYP3A4) inhibitors.
• Use of oral steroids within the last 1 month, or use of >/= 3 steroid bursts in the last 12 months.
• History of upper respiratory tract infection (URI) requiring treatment during the last month prior to Screening.
• Tobacco use within 3 months prior to Screening, or > 5 pack-year lifetime tobacco use.
• Use of smoking cessation therapy within 3 months prior to Screening.
• 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.
• History within past 6 months of alcohol abuse or illicit drug abuse.
• Myocardial infarction within 12 months prior to Screening.
• Known hypothyroidism, vitamin B12, or folic acid deficiency.
• Known systemic infection (HBV, HCV, HIV, TB).
• FSH level of < 35 IU/L and a LH level < 25 IU/L.
• Urine cotinine level > 50 ng/ml.
• Body Mass Index (BMI) <15 and >35.
• Participation in another clinical trial in the past 3 months.

Where it is running

• Clinical research Center of Alabama — Birmingham, Alabama, United States
• Medical Research of Arizona — Scottsdale, Arizona, United States
• California Allergy and Asthma Medical Group, Inc. — Los Angeles, California, United States
• California Allergy & Asthma Medical Group — Palmdale, California, United States
• Waterbury Pulmonary Associates — Waterbury, Connecticut, United States
• Avail Clinical Research LLC — DeLand, Florida, United States
• Sarasota Clinical Research — Sarasota, Florida, United States
• Florida Pulmonary Research Institute, Inc. — Winter Park, Florida, United States
• Allergy Partners of Western North Carolina — Asheville, North Carolina, United States
• Toledo Center for Clinical Research — Sylvania, Ohio, United States
• Allergy & Asthma Clinical Research Center — Oklahoma City, Oklahoma, United States
• Clinical Research Institute of Southern Oregon, PC — Medford, Oregon, United States
• Altoona Lung Specialists — Altoona, Pennsylvania, United States
• Allergy & Asthma Research of New Jersey, Inc. — Philadelphia, Pennsylvania, United States
• Spartanburg Medical Research — Spartanburg, South Carolina, United States
• Pioneer Research Solutions — Houston, Texas, United States
• Paragon Research — San Antonio, Texas, United States
• Utah Clinical Trials, LLC — Salt Lake City, Utah, United States
• VA Adult & Pediatric Allergy & Asthma PC — Richmond, Virginia, United States
• Pulmornary Consultants, PLLC — Tacoma, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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