NCT01449123

Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations

An Open-label Single Site Single Dose Pilot Study Using Mannitol Challenge Test With the Purpose to Explore Treatment With Fixed Dose Combinations in Adult Subjects With Asthma in Primary Care in Sweden

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Mundipharma AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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/formoterol (Innovair®) are optimal treated regarding the mannitol challenge test and the following reversibility test. The primary endpoint is to identify asthma patients responding positive or negative to the mannitol challenge test and/or the reversibility test. The hypothesis is that not all patients are well treated.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Mannitol challenge test & reversibility test	Patients perform an asthma control test (ACT) to establish if they are "well controlled" or "symptomatic". All patients will perform then perform the mannitol challenge test. Aridol™ is an indirect osmotic bronchial challenge test which can be used to identify bronchial hyperresponsiveness

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-10-10
• Last updated: 2012-08-09

Locations

1 site across 1 country: Sweden