Atopic AsthmaPhase 2NCT00861211
Safety and Efficacy Study of Oral Senicapoc on Allergen Challenge in Atopic Asthmatic Subjects
A Phase 2 study testing senicapoc in people with Atopic Asthma, run by Icagen at 2 sites in United Kingdom.
Trial summary
The purpose of the study is to determine whether senicapoc can decrease changes in FEV1 following allergen challenge in atopic allergic subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Asthma
- What is being tested?
- senicapoc
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2008to May 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of asthma (as defined by the Global Initiative in Asthma definition or having been previously treated for asthma);
- Baseline (pre-bronchodilator) forced expiratory volume at one second (FEV1) ≥70% of predicted;
- Clinically acceptable medical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests );
- Positive response on screening to skin prick test to either house dust mite, cat hair, or grass pollen;
- A positive inhaled methacholine challenge with a PC20 ≤ 8 mg/mL (within 6 months prior to Screening Visit 1);
- Screening allergen challenge demonstrates that the subject experiences both an early and late asthmatic response. The early asthmatic response must include a fall in FEV1 of equal to or more than 20% from the post saline value, on at least one occasion, between 5 and 30 minutes after the final concentration of allergen. The late asthmatic response must include a fall in FEV1 of equal to or more than 15% from the post saline value, on at least three occasions, two of which must be consecutive, between 4 and 10 hours after the final concentration of allergen;
- Non-smoker (refrained from any tobacco usage or any products containing nicotine for 6 months prior to Screening Visit 1);
- Able and willing to give written informed consent to participate in the study.
Who cannot join
- Any subject who has experienced any allergic reaction to a drug that suggests an increased potential for a hypersensitivity to senicapoc (e.g. clotrimazole);
- Previous ingestion of senicapoc (ICA-17043) prior to Screening Visit 1;
- Any condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs;
- Respiratory tract infection or asthma exacerbation within 4 weeks of the first Screening Visit or within the period between Screening Visit 1 and Day 1 unless study physician believes lung function was unaffected (no greater than 10% decrease in baseline FEV1) by such event;
- Considering or scheduled to undergo any surgical procedure during the duration of the study;
- History of alcohol and/or drug abuse within 2 years prior to Screening Visit 1;
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- Donation of blood (>450 mL) or significant loss of blood within 56 days prior to Screening Visit 1;
- Received any commercially licensed investigational product within 30 days prior to Screening Visit 1 or received any unlicensed investigational product within 90 days prior to Screening Visit 1;
- History of chronic hepatitis B or C, a positive test for hepatitis B surface antigen, hepatitis C antibody, a history of HIV infection, or demonstration of HIV antibodies;
- A positive qualitative urine drug test, a positive urine or breath alcohol test, or a positive urine cotinine or CO breath test at the first Screening visit or on Day 1;
- Use of oral or inhaled or intranasal corticosteroid, long acting beta agonists (e.g., salmeterol or formoterol), leukotriene receptor antagonists (e.g., zafirlukast or montelukast), theophylline, nedocromil sodium, cromolyn sodium, zileuton , or anti-cholinergic agents within the 28 days prior to the first Screening visit;
- Use of oral antihistamines within 1 week prior to the first Screening visit;
- Symptomatic with hay fever during any of the Screening Visits or Day 1;
- A >10 pack year cigarette history.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Guy's Drug Research Unit
London, UK, SE1 1YR
Medicines Evaluation Unit
Manchester, UK, M23 9QZ
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess The Safety and Efficacy of Two Weeks of Oral Senicapoc Administration on Allergen Challenge in Atopic Asthmatic Subjects
The purpose of the study is to determine whether senicapoc can decrease changes in FEV1 following allergen challenge in atopic allergic subjects.
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 allergen challenge in patients with allergic asthma. It is analogous to the study performed in animals in which senicapoc demonstrated the ability to reduce airway resistance and hyper-responsiveness induced by airway challenge with antigen and carbachol, respectively. This study is also the first to test the ability of senicapoc to reduce airway inflammation, which is the key pathophysiologic process in asthma. 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
- Atopic Asthma
- Being tested
- senicapoc, Placebo
- Keywords
- asthma, inflammation, bronchoconstriction, allergen challenge, KCa3.1
- Medical subject headings
- Asthma, 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 followed by Maintenance Dose: 40 mg daily x 11 days
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Active treatment arm | 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.
Decrease in FEV1 between 4-10 hours (Late Asthmatic Response) after allergen challenge and will compare the active (40 mg QD) vs. placebo treatment groups with respect to change in response to allergen challenge.
Measured: after 2 weeks of treatment with study medication
Secondary outcomes (1)
Early allergen response to allergen challenge, measure of airway hyperreactivity to methacholine challenge, pulmonary function tests (FEV1 and FVC), fraction of exhaled NO, cell differentials and cytokine measurements from induced sputum samples.
Measured: after 2 weeks of study medication
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 startOct 2008
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tak H Lee, FRCP, Principal investigator, Guy's Drug Research Unit, Quintiles Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861211
- Sponsor's protocol ID
- ICA-17043-17
- 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 Two Weeks of Oral Senicapoc Administration on Allergen Challenge in Atopic Asthmatic Subjects
- ClinicalTrials.gov ID
- NCT00861211
- Acronym / sponsor ID
- ICA-17043-17
- Conditions
- Atopic Asthma
- Keywords
- asthma, inflammation, bronchoconstriction, allergen challenge, KCa3.1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- IcagenIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 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 the study is to determine whether senicapoc can decrease changes in FEV1 following allergen challenge in atopic allergic subjects.
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 allergen challenge in patients with allergic asthma. It is analogous to the study performed in animals in which senicapoc demonstrated the ability to reduce airway resistance and hyper-responsiveness induced by airway challenge with antigen and carbachol, respectively. This study is also the first to test the ability of senicapoc to reduce airway inflammation, which is the key pathophysiologic process in asthma. 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 |
|---|---|---|
| Active treatment arm | Experimental | Drug: senicapoc |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- History of asthma (as defined by the Global Initiative in Asthma definition or having been previously treated for asthma);
- Baseline (pre-bronchodilator) forced expiratory volume at one second (FEV1) ≥70% of predicted;
- Clinically acceptable medical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests );
- Positive response on screening to skin prick test to either house dust mite, cat hair, or grass pollen;
- A positive inhaled methacholine challenge with a PC20 ≤ 8 mg/mL (within 6 months prior to Screening Visit 1);
Key exclusion criteria (14 listed)
- Any subject who has experienced any allergic reaction to a drug that suggests an increased potential for a hypersensitivity to senicapoc (e.g. clotrimazole);
- Previous ingestion of senicapoc (ICA-17043) prior to Screening Visit 1;
- Any condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs;
- Respiratory tract infection or asthma exacerbation within 4 weeks of the first Screening Visit or within the period between Screening Visit 1 and Day 1 unless study physician believes lung function was unaffected (no greater than 10% decrease in baseline FEV1) by such event;
- Considering or scheduled to undergo any surgical procedure during the duration of the study;
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 followed by Maintenance Dose: 40 mg daily x 11 days | Drug | Active treatment arm |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Decrease in FEV1 between 4-10 hours (Late Asthmatic Response) after allergen challenge and will compare the active (40 mg QD) vs. placebo treatment groups with respect to change in response to allergen challenge.
Time frame: after 2 weeks of treatment with study medication
1 secondary outcome
Early allergen response to allergen challenge, measure of airway hyperreactivity to methacholine challenge, pulmonary function tests (FEV1 and FVC), fraction of exhaled NO, cell differentials and cytokine measurements from induced sputum samples.
Time frame: after 2 weeks of study medication
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.
Tak H Lee, FRCP principal investigator
Guy's Drug Research Unit, Quintiles Limited
2 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 Atopic Asthma, run by Icagen at 2 sites in United Kingdom.
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 8 inclusion and 14 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 2 sites in United Kingdom. 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?
Decrease in FEV1 between 4-10 hours (Late Asthmatic Response) after allergen challenge and will compare the active (40 mg QD) vs. placebo treatment groups with respect to change in response to allergen challenge. (time frame: after 2 weeks of treatment with study medication). 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.