Asthma MedDRA version: 13.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Aridol
Pharmaceutical Form: Inhalation powder, hard capsule
CAS Number: 69-65-8
Other descriptive name: MANNITOL
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration
Sponsors
Mundipharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females, age 18-65 years. 2. Subjects diagnosed with asthma. 3. Subjects with a baseline FEV1 of =50% 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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with evidence of any other respiratory and/or obstructive disease. 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 |
|---|---|
| Main Objective: Explore if adult 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.;Secondary Objective: Explore how the asthma patients score themselves according the Asthma Control Test (ACT), “symptomatic” or “well-treated”. Explore how the Investigator evaluates the patients control of asthma, Asthma Score. ;Primary end point(s): • Mannitol challenge test (Aridol™) + short-acting ß2-agonist – positive response defined as one of the following: o =15% fall in FEV1 from baseline o 10% incremental fall in FEV1 between two consecutive doses in the test o Reversibility test with a short-acting ß2-agonist - increase in FEV1 of =15% ;Timepoint(s) of evaluation of this end point: At the day of the mannitol challenge test, visit nr. 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mannitol challenge test (Aridol™) – positive response defined as one of the following: o =15% fall in FEV1 from baseline o 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% • Asthma Control Test (ACT) – “symptomatic” or “well-treated” (by Subject) • Asthma Score – need for medication and severity of symptoms (by Investigator) • FEV1 values before, after and change during the Mannitol challenge test • FEV1 values before, after and change during the Reversibility test ;Timepoint(s) of evaluation of this end point: At the day of the mannitol challenge test, visit nr. 2 | — |
Countries
Sweden
Contacts
Public ContactMedical Manager
Mundipharma AB
Outcome results
None listed