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
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Mundipharma AB
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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