E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to moderate adult asthmatic patients |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | Low |
E.1.2 | Classification code | 10003553 |
|
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 |
To demonstrate the clinical superiority in terms of pulmonary function of CHF 1535 (formoterol and beclomethasone fixed combination) vs. a double dose of beclomethasone alone in the 12-week treatment period of mild to moderate persistent asthma in adult patients |
|
E.2.2 | Secondary objectives of the trial |
the evening PEF, the daily PEF variability (as reflect of bronchial hyper reactivity), morning and evening FEV1, FVC, FEV1/FVC, FEF25%, FEF75%, FEF25-75% calculated as the mean of the last 7 values obtained during the two last weeks of the treatment period, Pulmonary Function Tests performed at each visit. morning and evening asthma clinical symptoms scores, percentage of nights and/or days free of clinical symptoms. Asthma exacerbations as defined in protocol § 5.1.2. page 22/79 Asthma control defined as no or minimal clinical symptoms, no emergency visits, minimal need for SABAs, no limitation on activities, PEF diurnal variability < 20% and no adverse effects from drugs SABAs consumption. Adverse events and adverse drug reactions recording (described in chapter 9). Biological tests: Standard haematology and biochemistry. Morning serum cortisol. 12 hr overnight urine cortisol/creatinine ratio.
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients aged > 18 and < 70 years old. Males and non-pregnant females. Women of childbearing potential should have used an efficient contraception (oestro-progestatives, condoms and/or intra-uterine devices) for at least 1 month prior to inclusion and until study completion.· Having given their written informed consent. Clinical diagnosis of mild to moderate asthma, according to the Classification of Asthma Severity by Daily Medication Regimen and Response to Treatment of the Global Initiative for Asthma (GINA), Edition 2003.· Asthma treatment:Patients free of long-acting b2 agonists treatment (LABAs) at least for one month before the screening visit and already treated for at least 2 months with inhaled corticosteroids and experiencing (i) a daily use of short-acting b2-agonists (SABAs) between 1 and 4 puffs, (ii) and/or clinical symptoms ³ 3 times in the week prior to inclusion.The daily dose of inhaled corticosteroids should not be greater than: 400 µg of Budesonide 200 µg Mometasone furoate 500 µg of beclomethasone dipropionate or flunisolide 200 µg of fluticasone propionate 200 µg BDP extra fine.· FEV1 > 60% and < 85% of the predicted normal values.- A documented positive response to the reversibility test, defined as an improvement in FEV1 of > 12% of their baseline FEV1 and > 200 mL, 15 minutes after two puffs (2 ´ 100 µg) of inhaled salbutamol (pMDI) performed within the last two years. The condition causing the airflow obstruction should have been stable on the same regular treatment for at least 4 weeks. A cooperative attitude and ability to be trained in the proper use of a pMDI. |
|
E.4 | Principal exclusion criteria |
·Pregnant or lactating females or women of childbearing potential without any efficient contraception (oestro-progestatives, condoms and/or intra-uterine devices). Heavy smokers defined as smoking for > 10 pack year, Having received an investigational drug within 30 days before the current study.· Inability to perform outcome measurements optimally and to complete diary cards.· Patients with lack of personal freedom decreed by a judicial or administrative authority.· Patients not having signed their informed consent form.· Evidence of asthma exacerbation having caused a hospitalization (even for a short-period) or induced oral or parenteral corticosteroids treatment or evidence of symptomatic infection of the airways in the previous 4 weeks (3 months for slow-release corticosteroids). Seasonal asthma or asthma occurring only during episodic exposure to an allergen or an occupational chemical sensitizer. History of cystic fibrosis or bronchiectasis. History of clinically significant cardiac, renal, neurological, hepatic or endocrine diseases whose sequelae and/or treatments can interfere with the results of the present study. A particular oversight has to be kept towards patients with coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias, heart failure or diabetes mellitus. Any concomitant disease, which could interfere with the protocol according to investigator’s opinion. Intolerance or contra-indication to treatment with b2-agonists and/or inhaled corticosteroids. Allergy to one component of medications used (beclomethasone dipropionate, formoterol fumarate dihydrate, tetrafluoroethane-134a, anhydrous alcohol, norflurane, CFC-11, 12, lactose). Patients already chronically treated or treated within the previous month with inhaled LABAs Patients already receiving inhaled (including nasal) corticosteroids at a daily dose strictly greater than: 400 µg of Budesonide 200 µg Mometasone furoate 500 µg of beclomethasone dipropionate or flunisolide 200 µg of fluticasone propionate 200 µg BDP extra fine· Anti-asthmatic treatment modification within the month preceding inclusion. Patients already receiving sodium cromoglycate, nedocromil sodium, theophylline or leukotriene antagonists for whom the dose is likely to change during the 14-week study period. Patients treated with oral or parenteral corticosteroids in the previous month (3 months for slow-release corticosteroids). Patients treated with monoamine oxidase inhibitors, anticholinergics, tricyclic antidepressants or beta-blockers as regular use. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
the morning Peack Expiratory Flow at the end of the treatment period and it will be calculated as the mean of the last 7 values obtained during the two last weeks of the treatment period. |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
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 | |
E.8.9.2 | In all countries concerned by the trial months | 6 |