Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01449123
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : August 9, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Mannitol challenge test & reversibility test Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Mannitol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Inhaler
Subjects prescribed fixed dose combinations perform Mannitol Challenge Test and Reversibility Test once
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

Primary Outcome Measures :
  1. 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. ]
    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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01449123

Näsets Läkargrupp i Höllviken
Höllviken, Sweden
Sponsors and Collaborators
Mundipharma AB

Responsible Party: Mundipharma AB Identifier: NCT01449123     History of Changes
Other Study ID Numbers: FLT4501
2011-000939-86 ( EudraCT Number )
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: August 9, 2012
Last Verified: August 2012

Keywords provided by Mundipharma AB:
mannitol challenge test
primary care

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs