Allergic AsthmaPhase 2PEMAGNCT03119714
Pemirolast in Allergen Challenge (PEMAG)
A Phase 2 study testing Pemirolast in people with Allergic Asthma, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to establish the influence of the non-steroidal candidate-drug pemirolast on allergen-induced airway obstruction and inflammation in allergic subjects with asthma. Pemirolast is an orally available inhibitor of the release of mast cell mediators. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Pemirolast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2016to Feb 2018
- 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
- Age 18-65 years inclusive
- Diagnosed asthma as defined by at least one of the following:
- response to standard asthma treatment
- episodic wheezing
- change in lung function over short periods of time
- Non-smoker for the past two years and a total of smoking less than 5 pack-years
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- Stable intermittent asthma, only using bronchodilator therapy as needed for the last 4 weeks
- FEV1 ≥ 75 % of predicted
- A positive skin prick test to pollen (grass, birch, mugwort) or animal dander (dog, cat) and a history of associated symptoms on exposure.
Who cannot join
- Any significant respiratory disease, other than asthma.
- Subjects with seasonal asthma may not be included if they are in their season and subjects allergic to animal dander must not have a pet on their own or similar close exposure.
- Use of:
- Oral, injectable or inhaled glucocorticosteroid treatment for the last 4 weeks prior to inclusion or during the study
- Inhaled long-acting β2-agonists, anticholinergic bronchodilators, antihistamines, theofyllines, nasal or inhaled cromones and antileukotrienes within 2 weeks of screening
- Beta-blocking agents.
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- Immunomodulator drugs
- NSAIDs.
- Upper or lower respiratory tract infection within 4 weeks of screening
- Females who are pregnant, intend to be or who are lactating. Female subjects of childbearing potential who are not willing to use adequate contraceptive methods (measures as required by local requirements or practice) during participation in the trial until at least three days after last intake of study treatments. Male subjects not surgically sterilized, who or whose partner is not using adequate contraceptive methods (measures as required by local requirements or practice) during participation in the trial until at least three days after last intake of study drug.
- Subjects with BMI >30.
- Evidence (from clinical laboratory tests, physical examination or medical history) of hepatic disease (other than Gilbert´s Syndrome)
- Evidence (from physical examination or medical history) of any diseases that affects gastrointestinal absorption.
- A diagnosis of brittle asthma (rapid fluctuations in disease severity).
- Participation in other study in the four weeks prior to screening.
- Evidence of drug or alcohol abuse.
- History of having taken barbiturates or other drugs affecting the liver drug-metabolising enzymes within one month of the start of the trial.
- Blood donor during the last four months prior to study start and throughout the study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Lung and Allergy Research Unit C2-88 Karolinska University Hospital Huddinge
Stockholm, 14186
About this study
Official title: A Placebo-controlled, Cross-over, Study to Assess the Efficacy of the Oral Mast Cell Inhibitor Pemirolast in Allergen-induced Airway Obstruction and Inflammation in Subjects With Allergic Asthma
The purpose of this study is to establish the influence of the non-steroidal candidate-drug pemirolast on allergen-induced airway obstruction and inflammation in allergic subjects with asthma. Pemirolast is an orally available inhibitor of the release of mast cell mediators. The study will therefore test the hypothesis that global inhibition of the mast cell, resulting in decreased production of most of its mediator molecules, will provide a highly significant anti-asthmatic effect.
Read the detailed description
This is a crossover randomized double blind, placebo-controlled study where the early and late response to allergen inhalation challenge will be compared during two treatment periods, with pemirolast 200 mg bid for 14 (to 16) days and matching placebo, respectively. Non-smoking female and male subjects (n = 12-15) with intermittent atopic asthma, requiring only β2-agonists to treat their asthma, will be recruited. A total of twelve subjects who demonstrate an early and a late asthmatic response to inhaled allergen challenge are required to complete the study for the primary end-point. The sample size is sufficient according to experience from a large number of studies and published power calculations of the model. The effects of pemirolast have never been studied before in an allergen provocation model. Primary variable is the effect of treatment on the mean maximum fall in forced expiratory volume in one second (FEV1) during the early and the late asthmatic reactions induced by allergen. Secondary variables are the effect on mast cell activation and airway inflammation measured as the urinary excretion of metabolites of prostaglandins and other lipid mediators and the percentage of sputum eosinophils, respectively. Tertiary variables are the effect of treatment on airway responsiveness expressed as the provocative dose of methacholine causing 20 per cent decrease in FEV1 (PD20FEV1), as well as biomarkers of airway inflammation in saliva, sputum, exhaled air and blood.
- Conditions
- Allergic Asthma
- Being tested
- Pemirolast, Placebo Oral Tablet
- Keywords
- bronchoprovocation, early-late asthmatic reaction, mast cell stabilizer, mast cell mediators, sputum eosinophils
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemirolastDrug
Also called CRD 007
Treatment with pemirolast 200 mg bid for 14-16 days
Placebo Oral TabletDrug
Treatment with placebo bid for 14-16 days
| Study group | Role | What they receive |
|---|---|---|
| Pemirolast | Active comparator | Pemirolast 200mg bid 14-16 days Receives: Drug: Pemirolast |
| Placebo Oral Tablet | Placebo comparator | Matching placebo bid 14-16 days Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchoconstriction measured as fall in FEV1 during the early (EAR) and late (LAR) asthmatic reaction induced by allergen
Measured: After treatment with pemirolast or matching placebo for 14-16 days
Secondary outcomes (2)
Mast cell activation measured as urinary excretion of metabolites of lipid mediators (prostaglandins,isoprostanes,leukotrienes,tromboxanes)
Urine samples will be analysed with mass spectrometry (UPLC-MS/MS) and data presented as ng.mmol creatinine-1 for all metabolites
Measured: After treatment with pemirolast or matching placebo for 14-16 days
Airway inflammation measured as the percentage of sputum eosinophils
Induced sputum will be collected 7 hours after the last inhaled allergen dose and percentage of eosinophils will be measured
Measured: After treatment with pemirolast or matching placebo for 14-16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startNov 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: Due to results from other studies regarding efficacy of pemirolast
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Unit for Chemistry II, Department of Medical Biochemistry, Karolinska Institutet, Occupational and Environmental Medicine, Sahlgrenska UH, Gothenburg, Div Clinical Pharmacology, Karolinska University Hospital, Dept. Respiratory Medicine, University of Amsterdam, Amsterdam
- Responsible party
- Principal investigator, Barbro Dahlen, Karolinska University Hospital
- Investigators
- Barbro Dahlén, MD,PhD, Principal investigator, Lung and Allergy Clinic, Karolinska UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119714
- Sponsor's protocol ID
- PEMAG-2016-v2.3
- Acronym
- PEMAG
- Status last verified
- May 2019
- First submitted
- 11 Nov 2016
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Not planing to share data
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Cross-over, Study to Assess the Efficacy of the Oral Mast Cell Inhibitor Pemirolast in Allergen-induced Airway Obstruction and Inflammation in Subjects With Allergic Asthma
- ClinicalTrials.gov ID
- NCT03119714
- Acronym / sponsor ID
- PEMAG / PEMAG-2016-v2.3
- Conditions
- Allergic Asthma
- Keywords
- bronchoprovocation, early-late asthmatic reaction, mast cell stabilizer, mast cell mediators, sputum eosinophils
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to results from other studies regarding efficacy of pemirolast
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Unit for Chemistry II, Department of Medical Biochemistry, Karolinska Institutet, Occupational and Environmental Medicine, Sahlgrenska UH, Gothenburg, Div Clinical Pharmacology, Karolinska University Hospital, Dept. Respiratory Medicine, University of Amsterdam, Amsterdam
- Study start
- Nov 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 19 Apr 2017 (actual)
- 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 establish the influence of the non-steroidal candidate-drug pemirolast on allergen-induced airway obstruction and inflammation in allergic subjects with asthma. Pemirolast is an orally available inhibitor of the release of mast cell mediators. The study will therefore test the hypothesis that global inhibition of the mast cell, resulting in decreased production of most of its mediator molecules, will provide a highly significant anti-asthmatic effect.
Detailed description
This is a crossover randomized double blind, placebo-controlled study where the early and late response to allergen inhalation challenge will be compared during two treatment periods, with pemirolast 200 mg bid for 14 (to 16) days and matching placebo, respectively. Non-smoking female and male subjects (n = 12-15) with intermittent atopic asthma, requiring only β2-agonists to treat their asthma, will be recruited. A total of twelve subjects who demonstrate an early and a late asthmatic response to inhaled allergen challenge are required to complete the study for the primary end-point. The sample size is sufficient according to experience from a large number of studies and published power calculations of the model. The effects of pemirolast have never been studied before in an allergen provocation model. Primary variable is the effect of treatment on the mean maximum fall in forced expiratory volume in one second (FEV1) during the early and the late asthmatic reactions induced by allergen. Secondary variables are the effect on mast cell activation and airway inflammation measured as the urinary excretion of metabolites of prostaglandins and other lipid mediators and the percentage of sputum eosinophils, respectively. Tertiary variables are the effect of treatment on airway responsiveness expressed as the provocative dose of methacholine causing 20 per cent decrease in FEV1 (PD20FEV1), as well as biomarkers of airway inflammation in saliva, sputum, exhaled air and blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemirolast | Active comparator | Drug: PemirolastPemirolast 200mg bid 14-16 days |
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral TabletMatching placebo bid 14-16 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-65 years inclusive
- Diagnosed asthma as defined by at least one of the following:
- Non-smoker for the past two years and a total of smoking less than 5 pack-years
- Stable intermittent asthma, only using bronchodilator therapy as needed for the last 4 weeks
- FEV1 ≥ 75 % of predicted
Key exclusion criteria (18 listed)
- Any significant respiratory disease, other than asthma.
- Subjects with seasonal asthma may not be included if they are in their season and subjects allergic to animal dander must not have a pet on their own or similar close exposure.
- Use of:
- Upper or lower respiratory tract infection within 4 weeks of screening
- Females who are pregnant, intend to be or who are lactating. Female subjects of childbearing potential who are not willing to use adequate contraceptive methods (measures as required by local requirements or practice) during participation in the trial until at least three days after last intake of study treatments. Male subjects not surgically sterilized, who or whose partner is not using adequate contraceptive methods (measures as required by local requirements or practice) during participation in the trial until at least three days after last intake of study drug.
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 |
|---|---|---|
| PemirolastAlso: CRD 007Treatment with pemirolast 200 mg bid for 14-16 days | Drug | Pemirolast |
| Placebo Oral TabletTreatment with placebo bid for 14-16 days | Drug | Placebo Oral Tablet |
Primary outcome
Bronchoconstriction measured as fall in FEV1 during the early (EAR) and late (LAR) asthmatic reaction induced by allergen
Time frame: After treatment with pemirolast or matching placebo for 14-16 days
2 secondary outcomes
Mast cell activation measured as urinary excretion of metabolites of lipid mediators (prostaglandins,isoprostanes,leukotrienes,tromboxanes)
Time frame: After treatment with pemirolast or matching placebo for 14-16 days
Airway inflammation measured as the percentage of sputum eosinophils
Time frame: After treatment with pemirolast or matching placebo for 14-16 days
Results and safety
The study was stopped early (reason given: Due to results from other studies regarding efficacy of pemirolast). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Individual participant dataSharing planned: No. Not planing to share data
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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.
Barbro Dahlén, MD,PhD principal investigator
Lung and Allergy Clinic, Karolinska UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemirolast in people with Allergic Asthma, run by Karolinska University Hospital at 1 site in Sweden.
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 9 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: stopped early, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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 was stopped early (reason given: Due to results from other studies regarding efficacy of pemirolast). Results are not available in the source record.
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?
Bronchoconstriction measured as fall in FEV1 during the early (EAR) and late (LAR) asthmatic reaction induced by allergen (time frame: After treatment with pemirolast or matching placebo for 14-16 days). 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 8 May 2019.