TC-6987 for the Treatment of Mild to Moderate Asthma

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Targacept Inc.

Criteria

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.