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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
History of Changes
  Purpose

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 Intervention Phase
Asthma
 Drug: Mannitol challenge test & reversibility test
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Mundipharma AB:

Primary Outcome Measures:
  • 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.


Enrollment: 97
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449123

Locations
Sweden
Näsets Läkargrupp i Höllviken
Höllviken, Sweden
Sponsors and Collaborators
Mundipharma AB
  More Information

No publications provided

Responsible Party: Mundipharma AB
ClinicalTrials.gov Identifier: NCT01449123     History of Changes
Other Study ID Numbers: FLT4501, 2011-000939-86
Study First Received: September 8, 2011
Last Updated: August 8, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Mundipharma AB:
Asthma
mannitol challenge test
Sweden
primary care

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013