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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01449123

Enrollment

Registered

2011-10-10

Start date

2011-09-30

Completion date

2012-04-30

Last updated

2012-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, mannitol challenge test, Sweden, primary care

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.

Interventions

DRUGMannitol 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026