Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations
Information source: Mundipharma AB
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Mannitol challenge test & reversibility test (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Mundipharma AB Overall contact:
Margaret C Wilson, Email: info@contact-clinical-trial.com
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.
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mannitol challenge test (Aridol™) + short-acting β2-agonist - positive response.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion criteria
1. Males and females, age 18-65 years.
2. Subjects diagnosed with asthma.
3. Subjects with a baseline FEV1 of ≥70% 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.
Exclusion Criteria
1. Subjects with evidence of any other respiratory and/or obstructive disease including
recent infection/exacerbation.
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.
Locations and Contacts
Margaret C Wilson, Email: info@contact-clinical-trial.com
Näsets Läkargrupp i Höllviken, Höllviken, Sweden; Recruiting
Additional Information
Starting date: September 2011
Last updated: October 7, 2011
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