Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Näsets Läkargrupp i Höllviken

Höllviken, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males and females, age 18-65 years.
Subjects diagnosed with asthma.
Subjects with a baseline FEV1 of ≥70% of the predicted value.
Outpatients at primary clinic.
Subjects treated with a fixed dose combination for at least the last three months.
Subjects who have withheld their asthma- and allergy medication according to individual instructions at the day of the challenge test.
Subjects who are able to read and comprehend Swedish and are willing to sign an informed consent.

Exclusion criteria

Subjects with evidence of any other respiratory and/or obstructive disease including recent infection/exacerbation.
Subjects treated with a oral corticosteroid within 4 weeks (28 days) prior to the day of the challenge test.
Any history of hypersensitivity to mannitol challenge test.
Any contraindications to use of the diagnostic study medication.
Subjects who are unsuitable for other reason(s) in the opinion of the investigator.

Treatment and study plan

Mannitol challenge test & reversibility test

Drug

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Mundipharma AB

Industry

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Oct 10, 2011
Registry last updated: Aug 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed