Mannitol challenge test in adult asthma patients with fixed dose combination - Pilot

• Conditions: Asthma; MedDRA version: 13.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-000939-86-SE
• Lead Sponsor: Mundipharma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-29
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified