A DOUBLE BLIND, SINGLE DOSE, RANDOMIZED, 4-PERIOD CROSS-OVER, PLACEBO-CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE (CHF 1535) VERSUS SINGLE AGENTS FORMOTEROL FUMARATE AND BECLOMETHASONE DIPROPIONATE VIA pMDI WITH HFA-134A PROPELLANT, WHEN GIVEN AFTER INHALED ALLERGEN CHALLENGE IN ASTHMATIC PATIENTS - MART3
- Conditions
- astma
- Registration Number
- EUCTR2008-002844-40-NL
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
-Written informed consent;
-Male and female outpatients, aged ? 18 years and ? 55 years;
-Clinical diagnosis of controlled asthma for at least 6 months, according to Global Strategy for Asthma Management and Prevention (GINA) revised version 2007 guidelines, without severe exacerbation in the previous 6 months;
-Patients on short-acting ?2-agonists on needed, as the only asthma therapy;
-A provocative concentration (PC) of methacholine chloride or histamine causing a 20% fall in FEV1 (PC20) < 16 mg/ml;
-A positive skin prick test (SPT) for house dust mite (HDM);
-An EAR (? 20% fall in FEV1 from baseline, 0-3 h post allergen) and a LAR (? 15% fall in FEV1 from baseline, 3-8 h post-allergen) following inhaled allergen extract at screening;
-A co-operative attitude and ability to correctly use the device.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Current smokers or recent (less than one year) ex-smokers with a smoking history less than 10 pack years;
-Clinically significant history of upper/lower respiratory tract infection within 4 weeks from the start of the study;
-Clinically significant or unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; significant other pulmonary disease; cardiovascular disease; gastrointestinal disease; neurological disease; haematological disease, autoimmune disorders, laboratory and electrocardiographyc abnormalities that may interfere with patient’s safety, compliance, or study evaluations, according to the investigator’s opinion;
-Pregnant or lactating women. Females of childbearing potential with active desire to be pregnant or without an efficient contraception method. A negative pregnancy test in urine is to be verified in women of a fertile age at screening;
-Patients treated with long-acting ?2-agonists, anticholinergics and antihistamines in the previous week;
-Patients treated with leukotriene antagonists during the previous 2 weeks;
-Patients treated with inhaled or nasal corticosteroids in the previous 4 weeks;
-Patients treated for immunotherapy;
-Patients treated with anti-IgE antibodies in the previous 6 months;
-Patients treated with beta-blockers in the week preceding the screening visit;
-Patients who received systemic steroids in the last month;
-Significant alcohol consumption or drug abuse;
-Patients with allergy, sensitivity or intolerance to sympathomimetic drugs or corticosteroids or to any of the excipients contained in the study drugs;
-Inability to perform spirometry of acceptable quality (according to ERS guidelines) or any other acute or chronic condition that put the patient at risk or may alter the interpretation of the test;
-Patients who received any investigational new drug or participated in clinical study within the previous 8 weeks before study entry.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method