Exercise Induced AsthmaPhase 2NCT00861185
Study to Assess Safety and Efficacy of Oral Senicapoc Administration on Exercise-induced Asthma
A Phase 2 study testing senicapoc in people with Exercise Induced Asthma, run by Icagen at 9 sites in United States.
Trial summary
The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates exercise induced asthma symptoms. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Exercise Induced Asthma
- What is being tested?
- senicapoc
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2009to Sep 2009
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able and willing to give written informed consent to participate in the study as HIPAA authorization;
- Clinically acceptable medical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests
- History of physician-diagnosed asthma according to Global Initiative for Asthma, AND exercise-induced asthma/ bronchoconstriction;
- Current treatment for asthma with short-acting inhaled beta-2-agonist ONLY;
- Baseline FEV1 >65% of predicted at Screen Visit 1;
- A 20% or greater drop in FEV1 following exercise challenge on at least two separate occasions prior to enrollment;
- Non-smoker (refrained from any tobacco usage, or any products containing nicotine, for 6 months prior to Day 1);
Who cannot join
- Subject who has experienced any allergic reaction to a drug which, suggests an increased potential for a hypersensitivity to senicapoc (e.g., clotrimazole);
- Previous ingestion of senicapoc (ICA-17043)
- Pregnant or lactating female;
- Condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs; subjects who have had any previous gastrointestinal surgery, except appendectomy or cholecystectomy (if performed more than 90 days prior to Screening Visit 1) or a history of clinically significant active cardiovascular, neurologic, endocrine, hepatic, or renal disorders;
- Infectious illness, e.g. acute bacterial, acute and chronic parasitic, fungal infection or viral infection within 6 weeks prior to Screening Visit 1 or between Screening Visit 1 and Day 1 (Randomization).
- Treatment for conditions other than asthma with systemic corticosteroids within 1 month prior to Visit 1.
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- Asthma exacerbation having necessitated treatment with inhaled corticosteroids within 6 weeks prior to study Screening Visit 1.
- History of severe asthma as defined by use of oral/injectable corticosteroids within the last 3 months and/or more than two bursts in the last year.
- Undergoing desensitization therapy unless on a maintenance dose for at least 3 months prior to entry and will continue as such throughout study participation.
- History of chronic pulmonary diseases other than asthma.
- Considering or scheduled to undergo any surgical procedure during the duration of the study;
- Ingestion of any investigational medication within 30 days prior to Screening Visit 1;
- A positive plasma alcohol, or urine cotinine test at Screening Visit 1;
- Use of the following asthma medications for the stated period prior to Screening Visit 1 and throughout the study:
- Oral or parenteral corticosteroids within 3 months prior to Screening Visit 1
- Inhaled corticosteroids (ICS) (e.g., budesonide, fluticasone propionate) within 1 month prior to Screening Visit 1
- long acting beta agonists; leukotriene receptor antagonists; or anti-cholinergic agents (e.g. tiotropium) within the 2 weeks prior to Screening Visit;
- Use of antihistamines within 3 days prior to Screening Visit 1;
- Has a >10 pack-year history of smoking;
- Hypertension at screen (BP > 150/90), if deemed by Investigator to be unfit to complete exercise challenge testing;
- Screen QTc > 450 msec or ECG not suitable for QT measurement (e.g., poorly defined termination of T-wave);
- After exercise challenge test, subject not recovering to at least 90% of baseline FEV1 following administration of short-acting beta-2-agonist.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Canton, Ohio, 44718
Study site
Huntington Beach, California, 92647
Study site
Metairie, Louisiana, 70006
Study site
Normal, Illinois, 61761
Study site
North Syracuse, New York, 13212
Study site
Orange, California, 92868
Study site
Seattle, Washington, 98105
Study site
Skillman, New Jersey, 08558
Study site
St Louis, Missouri, 63141
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Safety and Efficacy of Four Weeks of Oral Senicapoc Administration on Exercise-Induced Asthma
The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates exercise induced asthma symptoms.
Read the detailed description
Based on the unmet medical need for new agents in the treatment of asthma and the role of KCa3.1 in the function of several different cell types involved in the inflammatory response, and the effects seen in an animal model of allergic asthma, it is reasonable to explore the utility of senicapoc, a KCa3.1 blocker, as a novel treatment of asthma. This study will test the ability of senicapoc to alleviate bronchospasm induced by an exercise challenge in subjects with asthma. Exercise challenge studies have been conducted for many currently approved asthma medications. Exercise challenge studies provide a controlled environment and test conditions to investigate the potential usefulness of novel study drugs for the treatment of asthma. This study will be the first to test the ability of senicapoc to reduce airway bronchospasm after exercise challenge, which is one clinically important manifestation of asthma seen in patients. In summary, with a demonstrated safety profile across a wide range of doses in humans and efficacy in an animal model of allergic bronchospasm and hyper-responsiveness, the initiation of exploratory studies of senicapoc for treatment of asthma is justified.
- Conditions
- Exercise Induced Asthma
- Being tested
- senicapoc, Placebo
- Keywords
- bronchospasm, exercise asthma, inflammation, KCa3.1
- Medical subject headings
- Asthma, Exercise-Induced, Bronchial Spasm, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
senicapocDrug
Also called ICA-17043
Loading Dose: 80 mg twice daily x 3 days Maintenance Dose: 40 mg daily for remainder of the treatment period (total 4 weeks)
PlaceboDrug
Placebo looks identical to active study medication and will be dosed according to the same dosing regimen
| Study group | Role | What they receive |
|---|---|---|
| Senicapoc | Experimental | Not described Receives: Drug: senicapoc |
| 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.
The change from baseline in the maximal percentage decrease in forced expiratory volume in one second (FEV1) after exercise
Measured: Week 2 and Week 4
Secondary outcomes (1)
- Area under the curve (AUC) for FEV1 after exercise challenge, - the length of time for recovery of FEV1 after exercise challenge, - changes in non-challenge pulmonary function tests, and an asthma control questionnaire.
Measured: Week 2 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Induced 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jonathon Stocker, Ph.D., Study director, Icagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861185
- Sponsor's protocol ID
- ICA-17043-18
- Status last verified
- Jul 2011
- First submitted
- 12 Mar 2009
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Safety and Efficacy of Four Weeks of Oral Senicapoc Administration on Exercise-Induced Asthma
- ClinicalTrials.gov ID
- NCT00861185
- Acronym / sponsor ID
- ICA-17043-18
- Conditions
- Exercise Induced Asthma
- Keywords
- bronchospasm, exercise asthma, inflammation, KCa3.1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- IcagenIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 13 Mar 2009 (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.
The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates exercise induced asthma symptoms.
Detailed description
Based on the unmet medical need for new agents in the treatment of asthma and the role of KCa3.1 in the function of several different cell types involved in the inflammatory response, and the effects seen in an animal model of allergic asthma, it is reasonable to explore the utility of senicapoc, a KCa3.1 blocker, as a novel treatment of asthma. This study will test the ability of senicapoc to alleviate bronchospasm induced by an exercise challenge in subjects with asthma. Exercise challenge studies have been conducted for many currently approved asthma medications. Exercise challenge studies provide a controlled environment and test conditions to investigate the potential usefulness of novel study drugs for the treatment of asthma. This study will be the first to test the ability of senicapoc to reduce airway bronchospasm after exercise challenge, which is one clinically important manifestation of asthma seen in patients. In summary, with a demonstrated safety profile across a wide range of doses in humans and efficacy in an animal model of allergic bronchospasm and hyper-responsiveness, the initiation of exploratory studies of senicapoc for treatment of asthma is justified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Senicapoc | Experimental | Drug: senicapoc |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Able and willing to give written informed consent to participate in the study as HIPAA authorization;
- Clinically acceptable medical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests
- History of physician-diagnosed asthma according to Global Initiative for Asthma, AND exercise-induced asthma/ bronchoconstriction;
- Current treatment for asthma with short-acting inhaled beta-2-agonist ONLY;
- Baseline FEV1 >65% of predicted at Screen Visit 1;
Key exclusion criteria (22 listed)
- Subject who has experienced any allergic reaction to a drug which, suggests an increased potential for a hypersensitivity to senicapoc (e.g., clotrimazole);
- Previous ingestion of senicapoc (ICA-17043)
- Pregnant or lactating female;
- Condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs; subjects who have had any previous gastrointestinal surgery, except appendectomy or cholecystectomy (if performed more than 90 days prior to Screening Visit 1) or a history of clinically significant active cardiovascular, neurologic, endocrine, hepatic, or renal disorders;
- Infectious illness, e.g. acute bacterial, acute and chronic parasitic, fungal infection or viral infection within 6 weeks prior to Screening Visit 1 or between Screening Visit 1 and Day 1 (Randomization).
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 |
|---|---|---|
| senicapocAlso: ICA-17043Loading Dose: 80 mg twice daily x 3 days Maintenance Dose: 40 mg daily for remainder of the treatment period (total 4 weeks) | Drug | Senicapoc |
| PlaceboPlacebo looks identical to active study medication and will be dosed according to the same dosing regimen | Drug | Placebo |
Primary outcome
The change from baseline in the maximal percentage decrease in forced expiratory volume in one second (FEV1) after exercise
Time frame: Week 2 and Week 4
1 secondary outcome
- Area under the curve (AUC) for FEV1 after exercise challenge, - the length of time for recovery of FEV1 after exercise challenge, - changes in non-challenge pulmonary function tests, and an asthma control questionnaire.
Time frame: Week 2 and Week 4
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 14 Jul 2011.
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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.
Jonathon Stocker, Ph.D. study director
Icagen
9 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 senicapoc in people with Exercise Induced Asthma, run by Icagen at 9 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 7 inclusion and 22 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 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The change from baseline in the maximal percentage decrease in forced expiratory volume in one second (FEV1) after exercise (time frame: Week 2 and Week 4). 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 14 Jul 2011.