Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations

NCT01449123 | Completed Phase 4

• 2 other identifiers: FLT45012011-000939-86
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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

Keywords

Asthma; mannitol challenge test; Sweden; primary care

Outcome Measures

Primary Outcomes (1)

• Mannitol challenge test (Aridol™) + short-acting β2-agonist - positive response.

  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.

  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.

Study Arms (1)

Inhaler

EXPERIMENTAL

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

Drug: Mannitol challenge test & reversibility test

Interventions

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

Inhaler

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma AB: lead

Study Sites (1)

Näsets Läkargrupp i Höllviken

Höllviken, Sweden

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: October 10, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 9, 2012

Record last verified: 2012-08

Locations

SE (1)