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Clinical Trials/EUCTR2011-000939-86-SE
EUCTR2011-000939-86-SEActive, not recruitingNot Applicable

An open-label single site single dose pilotstudy using mannitol challenge test with the purpose to explore treatment with fixed dose combinations in adult subjects with asthma in primary care in Sweden - Mannitol Pilot

Mundipharma AB0 sitesStarted: April 29, 2011Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • 1. Males and females, age 18-65 years.
  • 2. Subjects diagnosed with asthma.
  • 3. Subjects with a baseline FEV1 of =50% of the predicted value.
  • 4. Outpatients at primary clinic.
  • 5. Subjects treated with a fixed dose combination for at least the last three months.
  • 6. Subjects who have withheld their asthma- and allergy medication according to individual instructions at the day of the challenge test.
  • 7. Subjects who are able to read and comprehend Swedish and are willing to sign an informed consent.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 100
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • 1. Subjects with evidence of any other respiratory and/or obstructive disease.
  • 2. Subjects treated with a oral corticosteroid within 4 weeks (28 days) prior to the day of the challenge test.
  • 3. Any history of hypersensitivity to mannitol challenge test.
  • 4. Any contraindications to use of the diagnostic study medication.
  • 5. Subjects who are unsuitable for other reason(s) in the opinion of the investigator.

Investigators

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