E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 |
The primary objective is to compare the effect of the two treatments on airway responsiveness to methacholine.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives will be effects on salbutamol recovery following methacholine challenge, mannitol challenge, assessment of the effect of the two treatments on spirometry, exhaled nitric oxide, asthma symptoms, peak flow, peripheral blood eosinophils and serum eosinophilic cationic protein, Bmax, Emax, IOS (Impulse oscillometry) and overnight urinary cortisol/creatinine.
Safety assessments will be vital signs, laboratory assessments and adverse events. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent given by patient. 2. Male or female patients between 18 and 65 years of age inclusive. 3. Persistent stable asthmatics (FEV1 > 60%) on ≤ 1000 μg FP or equivalent or if on combination therapy up to 500 μg of FP or equivalent (e.g. FP/SM 125 2-puffs BD or BUD/FM 200/6 2-puffs BD) 4. Patients suffering from stable, persistent, mild to moderate asthma as defined by GINA Guidelines and for whom FEV1 > 60 % 5. Methacholine PC20 < 4mg/ml with a doubling dose (2dd) shift in PC20 after 400µg of salbutamol after wash-out (i.e. to identify ß2 responders). 6. In the opinion of the investigator, able and willing to comply with the requirements of the protocol.
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E.4 | Principal exclusion criteria |
1. Severe asthmatics as defined by an FEV1 < 60% or PEF variability >30% or with continual daytime or nocturnal symptoms. 2. Known or suspected hypersensitivity to FP or any other constituents of the Test or Reference pMDI 3. Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study (such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA / CVA). 4. Females who are pregnant, lactating or planning to become pregnant. 5. Approximately half of the subjects will be smokers and half currently non-smokers (or who have ceased smoking at least 1 year previously). 6. Clinically significant laboratory values, as judged by the investigator. 7. Patients who have previously been enrolled into this study. 8. Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the screening visit. 9. Patients who are scheduled to receive any other investigational drug during the course of the study. 10. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial. 11. Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months. 12. Respiratory tract infection in the previous 2 months. 13. Patients with significant concomitant respiratory disease such as COPD, CF, ABPA, active pulmonary TB or bronchiectesis.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Efficacy Endpoint: Change from placebo baseline in methacholine airway responsiveness measured as doubling dilution shift in PC20 for each treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | 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 | Information not present in EudraCT |
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
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The end of the study is defined as Last Subject Last Visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |