TC-6987 for the Treatment of Mild to Moderate Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296087
• Other study ID #: TC-6987-23-CRD-001
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2011
• Last updated: September 3, 2013
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2012
• Source: Targacept Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• TC-6987
TC-6987 50 mg capsule given once daily on Days 1 to 28
• Placebo
Matching placebo capsule given once daily on Days 1 to 28

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Targacept Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FEV1 status on Day 28 compared to baseline as a function of treatment (TC-6987 versus placebo)	Co-primary efficacy endpoints: the change in FEV1 from pre dose on Day 1 to pre dose on Day 28; the change in FEV1 from pre dose on Day 1 to 2 h post dose on Day 28	Day 28	No
Secondary	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	Day 1	No
Secondary	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	Day 29	No
Secondary	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	Day 28	No