Status:
COMPLETED
Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations
Lead Sponsor:
Mundipharma AB
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The primary objective in this pilot study is to explore if asthma patients prescribed fixed dose combinations (budenosid/formoterol (Symbicort®), salmeterol/fluticasone (Seretide®), beclometasone/form...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Males and females, age 18-65 years.
- Subjects diagnosed with asthma.
- Subjects with a baseline FEV1 of ≥70% of the predicted value.
- Outpatients at primary clinic.
- Subjects treated with a fixed dose combination for at least the last three months.
- Subjects who have withheld their asthma- and allergy medication according to individual instructions at the day of the challenge test.
- Subjects who are able to read and comprehend Swedish and are willing to sign an informed consent.
- Exclusion Criteria
- Subjects with evidence of any other respiratory and/or obstructive disease including recent infection/exacerbation.
- Subjects treated with a oral corticosteroid within 4 weeks (28 days) prior to the day of the challenge test.
- Any history of hypersensitivity to mannitol challenge test.
- Any contraindications to use of the diagnostic study medication.
- Subjects who are unsuitable for other reason(s) in the opinion of the investigator.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01449123
Start Date
September 1 2011
End Date
April 1 2012
Last Update
August 9 2012
Active Locations (1)
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1
Näsets Läkargrupp i Höllviken
Höllviken, Sweden