E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Mannitol challenge test (Aridol™) + short-acting β2-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 β2-agonist - increase in FEV1 of ≥15%
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the day of the mannitol challenge test, visit nr. 2. |
|
E.5.2 | 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 β2-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
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the day of the mannitol challenge test, visit nr. 2 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Aridol is a diagnostic tool, no comparator |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit of last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |