Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449123
• Other study ID #: FLT4501
• Secondary ID: 2011-000939-86
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2011
• Last updated: August 8, 2012
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2012
• Source: Mundipharma AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Sweden	Näsets Läkargrupp i Höllviken	Höllviken

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mannitol challenge test (Aridol™) + short-acting ß2-agonist - positive response.	For the Primary efficacy variable, positive response Mannitol challenge test (Aridol™) followed by short-acting ß2-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 ß2-agonist - increase in FEV1 of =15% from the last dose of mannitol in the challenge test.	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.	No