Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations

NCT ID: NCT01449123

Last Updated: 2012-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-04-30

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.

Conditions

Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inhaler

Subjects prescribed fixed dose combinations perform Mannitol Challenge Test and Reversibility Test once

Group Type: EXPERIMENTAL

Mannitol challenge test & reversibility test

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Näsets Läkargrupp i Höllviken

Höllviken, , Sweden

Countries

Sweden

Other Identifiers

2011-000939-86

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FLT4501

Identifier Type: -

Identifier Source: org_study_id