TC-6987 for the Treatment of Mild to Moderate Asthma

NCT01296087 | Completed Phase 2

• 1 other identifier: TC-6987-23-CRD-001
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 21

Brief Summary

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

Conditions

Asthma

Keywords

Asthma; Mild to Moderate Asthma

Outcome Measures

Primary Outcomes (1)

• 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

  Day 28

Secondary Outcomes (3)

• Number of Asthma Control Days

  Day 1

• Decrease in FEV1 after methacholine dose as a function of treatment

  Day 29

• Number of Asthma Control Days

  Day 28

Study Arms (2)

TC-6987

EXPERIMENTAL

Drug: TC-6987

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TC-6987 DRUG

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

TC-6987

Placebo DRUG

Matching placebo capsule given once daily on Days 1 to 28

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Targacept Inc.: lead

Study Sites (21)

Clinical research Center of Alabama

Birmingham, Alabama, 35209, United States

Location

Medical Research of Arizona

Scottsdale, Arizona, 85251, United States

Location

California Allergy and Asthma Medical Group, Inc.

Los Angeles, California, 90025, United States

Location

California Allergy & Asthma Medical Group

Palmdale, California, 93551, United States

Location

Waterbury Pulmonary Associates

Waterbury, Connecticut, 06708, United States

Location

Avail Clinical Research LLC

DeLand, Florida, 32720, United States

Location

Sarasota Clinical Research

Sarasota, Florida, 34233, United States

Location

Florida Pulmonary Research Institute, Inc.

Winter Park, Florida, 32789, United States

Location

Allergy Partners of Western North Carolina

Asheville, North Carolina, 28801, United States

Location

Toledo Center for Clinical Research

Sylvania, Ohio, 43560, United States

Location

Allergy & Asthma Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, 97504, United States

Location

Altoona Lung Specialists

Altoona, Pennsylvania, 19115, United States

Location

Allergy & Asthma Research of New Jersey, Inc.

Philadelphia, Pennsylvania, 19115, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Pioneer Research Solutions

Houston, Texas, 77036, United States

Location

Paragon Research

San Antonio, Texas, 78205, United States

Location

Utah Clinical Trials, LLC

Salt Lake City, Utah, 84107, United States

Location

VA Adult & Pediatric Allergy & Asthma PC

Richmond, Virginia, 23229, United States

Location

Pulmornary Consultants, PLLC

Tacoma, Washington, 98405, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• John Winder, MD

  Toledo Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 15, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: September 13, 2013

Record last verified: 2012-07

Locations

US (21)