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Pemirolast in Allergen Challenge (PEMAG)

NCT03119714 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-05-08

No results posted yet for this study

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. 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.

Conditions

  • Allergic Asthma

Interventions

DRUG

Pemirolast

Treatment with pemirolast 200 mg bid for 14-16 days

DRUG

Placebo Oral Tablet

Treatment with placebo bid for 14-16 days

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Unit for Chemistry II, Department of Medical Biochemistry, Karolinska Institutet

    collaborator UNKNOWN

  • Occupational and Environmental Medicine, Sahlgrenska UH, Gothenburg

    collaborator UNKNOWN

  • Div Clinical Pharmacology, Karolinska University Hospital

    collaborator UNKNOWN

  • Dept. Respiratory Medicine, University of Amsterdam, Amsterdam

    collaborator UNKNOWN

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Barbro Dahlén, MD,PhD · Lung and Allergy Clinic, Karolinska UH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03119714 on ClinicalTrials.gov