Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma AB
ClinicalTrials.gov Identifier:
NCT01449123
First received: September 8, 2011
Last updated: August 8, 2012
Last verified: August 2012

September 8, 2011
August 8, 2012
September 2011
April 2012   (final data collection date for primary outcome measure)
Mannitol challenge test (Aridol™) + short-acting β2-agonist - positive response. [ Time Frame: 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. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01449123 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
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
Experimental: Inhaler
Subjects prescribed fixed dose combinations perform Mannitol Challenge Test and Reversibility Test once
Intervention: Drug: Mannitol challenge test & reversibility test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01449123
FLT4501, 2011-000939-86
No
Mundipharma AB
Mundipharma AB
Not Provided
Not Provided
Mundipharma AB
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP