Mannitol challenge test in adult asthma patients with fixed dose combination - Pilot

• Register: EUCTR
• Last refreshed on: 28 January 2013
• Main ID: EUCTR2011-000939-86-SE
• Date of registration: 29/04/2011
• Prospective Registration: Yes
• Primary sponsor: Mundipharma AB
• Public title: Mannitol challenge test in adult asthma patients with fixed dose combination - Pilot
• Scientific title: An open-label single site single dose pilotstudy using mannitol challenge test with the purpose to explore treatment with fixed dose combinations in adult subjects with asthma in primary care in Sweden - Mannitol Pilot
• Date of first enrolment: 16/06/2011
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000939-86
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Aridol is a diagnostic tool, no comparator Number of treatment arms in the trial: 1

Countries of recruitment

Sweden

Contacts

• Name: Medical Manager
• Affiliation: Mundipharma AB

• Name: Medical Manager
• Affiliation: Mundipharma AB

Key inclusion & exclusion 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:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Asthma
MedDRA version: 13.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

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 number: 635-

Primary Outcome(s)

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 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.

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 Outcome(s)

Timepoint(s) of evaluation of this end point: At the day of the mannitol challenge test, visit nr. 2

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

Secondary ID(s)

FLT4501

Source(s) of Monetary Support

Mundipharma AB