AsthmaPhase 2NCT01296087
TC-6987 for the Treatment of Mild to Moderate Asthma
A Phase 2 study testing TC-6987 in people with Asthma, run by Targacept Inc. at 21 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- TC-6987
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 21 sitesUnited States
- Study dates
- Feb 2011to Jan 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- Urine cotinine level > 50 ng/ml.
- Body Mass Index (BMI) <15 and >35.
- Participation in another clinical trial in the past 3 months.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Altoona Lung Specialists
Altoona, Pennsylvania, 19115
Allergy Partners of Western North Carolina
Asheville, North Carolina, 28801
Clinical research Center of Alabama
Birmingham, Alabama, 35209
Avail Clinical Research LLC
DeLand, Florida, 32720
Pioneer Research Solutions
Houston, Texas, 77036
California Allergy and Asthma Medical Group, Inc.
Los Angeles, California, 90025
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Allergy & Asthma Clinical Research Center
Oklahoma City, Oklahoma, 73120
California Allergy & Asthma Medical Group
Palmdale, California, 93551
Allergy & Asthma Research of New Jersey, Inc.
Philadelphia, Pennsylvania, 19115
VA Adult & Pediatric Allergy & Asthma PC
Richmond, Virginia, 23229
Utah Clinical Trials, LLC
Salt Lake City, Utah, 84107
Paragon Research
San Antonio, Texas, 78205
Sarasota Clinical Research
Sarasota, Florida, 34233
Medical Research of Arizona
Scottsdale, Arizona, 85251
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Toledo Center for Clinical Research
Sylvania, Ohio, 43560
Pulmornary Consultants, PLLC
Tacoma, Washington, 98405
Waterbury Pulmonary Associates
Waterbury, Connecticut, 06708
Florida Pulmonary Research Institute, Inc.
Winter Park, Florida, 32789
About this study
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
This study is designed to determine whether TC-6987 improves respiratory function in subjects with asthma by reducing airway hyper-responsiveness and inflammation.
Read the 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.
- Conditions
- Asthma
- Being tested
- TC-6987, Placebo
- Keywords
- Asthma, Mild to Moderate Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC-6987Drug
TC-6987 50 mg capsule given once daily on Days 1 to 28
PlaceboDrug
Matching placebo capsule given once daily on Days 1 to 28
| Study group | Role | What they receive |
|---|---|---|
| TC-6987 | Experimental | Not described Receives: Drug: TC-6987 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 28
Secondary outcomes (3)
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
Measured: Day 1
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
Measured: Day 29
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
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targacept Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Winder, MD, Principal investigator, Toledo Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296087
- Sponsor's protocol ID
- TC-6987-23-CRD-001
- Status last verified
- Jul 2012
- First submitted
- 11 Feb 2011
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01296087
- Acronym / sponsor ID
- TC-6987-23-CRD-001
- Conditions
- Asthma
- Keywords
- Asthma, Mild to Moderate Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Targacept Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TC-6987 | Experimental | Drug: TC-6987 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TC-6987TC-6987 50 mg capsule given once daily on Days 1 to 28 | Drug | TC-6987 |
| PlaceboMatching placebo capsule given once daily on Days 1 to 28 | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
Number of Asthma Control Days
Time frame: Day 1
Decrease in FEV1 after methacholine dose as a function of treatment
Time frame: Day 29
Number of Asthma Control Days
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Winder, MD principal investigator
Toledo Center for Clinical Research
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TC-6987 in people with Asthma, run by Targacept Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV1 status on Day 28 compared to baseline as a function of treatment (TC-6987 versus placebo) (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2013.