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TC-6987 for the Treatment of Mild to Moderate Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01296087
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : September 13, 2013
Information provided by (Responsible Party):
Targacept Inc.

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: TC-6987 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: TC-6987 Drug: TC-6987
TC-6987 50 mg capsule given once daily on Days 1 to 28

Placebo Comparator: Placebo Drug: Placebo
Matching placebo capsule given once daily on Days 1 to 28

Primary Outcome Measures :
  1. Change in FEV1 status on Day 28 compared to baseline as a function of treatment (TC-6987 versus placebo) [ Time Frame: Day 28 ]

    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

Secondary Outcome Measures :
  1. Number of Asthma Control Days [ Time Frame: Day 1 ]
    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

  2. Decrease in FEV1 after methacholine dose as a function of treatment [ Time Frame: Day 29 ]
    Percentage of patients in which methacholine dose decreases FEV1 by 20% (PC20) at Day 29 compared to Day -1

  3. Number of Asthma Control Days [ Time Frame: Day 28 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01296087

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Sponsors and Collaborators
Targacept Inc.
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Principal Investigator: John Winder, MD Toledo Center for Clinical Research
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Responsible Party: Targacept Inc. Identifier: NCT01296087    
Other Study ID Numbers: TC-6987-23-CRD-001
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: July 2012
Keywords provided by Targacept Inc.:
Mild to Moderate Asthma
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases