Clinical trial NCT01296087: TC-6987 for the Treatment of Mild to Moderate Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Mild to Moderate Asthma
Lead sponsor: Targacept Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-15
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change in FEV1 status on Day 28 compared to baseline as a function of treatment (TC-6987 versus placebo)
timeFrame: Day 28
Secondary outcomes:
measure: Number of Asthma Control Days
timeFrame: Day 1
measure: Decrease in FEV1 after methacholine dose as a function of treatment
timeFrame: Day 29
measure: Number of Asthma Control Days
timeFrame: Day 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical research Center of Alabama
state: Alabama
city: Scottsdale
country: United States
facility: Medical Research of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group, Inc.
state: California
city: Palmdale
country: United States
facility: California Allergy & Asthma Medical Group
state: California
city: Waterbury
country: United States
facility: Waterbury Pulmonary Associates
state: Connecticut
city: DeLand
country: United States
facility: Avail Clinical Research LLC
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute, Inc.
state: Florida
city: Asheville
country: United States
facility: Allergy Partners of Western North Carolina
state: North Carolina
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy & Asthma Clinical Research Center
state: Oklahoma
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC
state: Oregon
city: Altoona
country: United States
facility: Altoona Lung Specialists
state: Pennsylvania
city: Philadelphia
country: United States
facility: Allergy & Asthma Research of New Jersey, Inc.
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Houston
country: United States
facility: Pioneer Research Solutions
state: Texas
city: San Antonio
country: United States
facility: Paragon Research
state: Texas
city: Salt Lake City
country: United States
facility: Utah Clinical Trials, LLC
state: Utah
city: Richmond
country: United States
facility: VA Adult & Pediatric Allergy & Asthma PC
state: Virginia
city: Tacoma
country: United States
facility: Pulmornary Consultants, PLLC
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Toledo Center for Clinical Research
name: John Winder, MD
role: PRINCIPAL_INVESTIGATOR
References: