Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations
- Registration Number
- NCT01449123
- Lead Sponsor
- Mundipharma AB
- 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/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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Inhaler Mannitol challenge test & reversibility test Subjects prescribed fixed dose combinations perform Mannitol Challenge Test and Reversibility Test once
- Primary Outcome Measures
Name Time Method Mannitol challenge test (Aridol™) + short-acting β2-agonist - positive response. One day only (Day 1). Subjects complete an ACT, the mannitol challenge test and the reversibility test. This is the end of the study, there is no follow up. For the Primary efficacy variable, positive response Mannitol challenge test (Aridol™) followed by short-acting β2-agonist will be given as number and percentage for the ITT-population, as defined by the following: ≥15% fall in FEV1 from baseline; 10% incremental fall in FEV1 between two consecutive doses in the test; Reversibility test with a short-acting β2-agonist - increase in FEV1 of ≥15% from the last dose of mannitol in the challenge test.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Näsets Läkargrupp i Höllviken
🇸🇪Höllviken, Sweden