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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Written informed consent
- Male and female outpatients, aged * 18 years and * 55 years
- Clinical diagnosis of atopic controlled asthma for at least 6 months, according to Global Strategy for Asthma Management and Prevention (GINA) revised version 2006 Guidelines, without severe exacerbation in the previous 6 months before study entry
- Patients only taking short-acting *2-agonists on an as needed basis
- A provocative concentration of methacoline chloride or histamine causing a 20% fall in FEV1 (PC20) < 8 mg/ml
- A positive skin prick test (SPT) for house dust mite
- A documented 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
- A co-operative attitude and ability to correctly use the device

Exclusion Criteria

- Current smokers or recent (less than one year) ex-smokers
- Evidence of severe asthma exacerbation in the previous 6 months
- 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 electrocardiographic abnormalities that may interfere with patient*s safety, compliance, or study evaluations, according to the investigator*s opinion
- Female subjects: pregnant or with active desire to be pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (i.e. contraceptive methods other than oral contraceptives, IUD, tubal ligature). A pregnancy test in urine is to be carried out in women of a fertile age at screening
- Patients treated with long-acting *2-agonists, anticholinergics and antihistamines and with topicalcorticosteroids and leukotriene antagonists during the previous 4 weeks
- Patients treated with beta-blockers in the week preceding the screening visit
- Patients who received systemic steroids in the previous 2 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To demonstrate that CHF 1535 as single administration is superior to single<br /><br>components and to placebo in terms of late asthmatic response (LAR), when given<br /><br>after inhaled allergen challenge.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the effects of the study drugs on early asthmatic response (EAR),<br /><br>airway hyperresponsiveness, induced sputum differential cell counts and<br /><br>inflammatory mediators in supernatant, fractional exhaled nitric oxide (FeNO)<br /><br>values and changes in VOCs behaviour.</p><br>