astma
Conditions
Interventions
Product Name: CHF 718 HFA
Product Code: CHF 718 HFA
Pharmaceutical Form: Inhalation vapour, solution
Pharmaceutical form of the placebo: Inhalation vapour, solution
Route of administration of the plac
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective will be to demonstrate that Foster as single administration is superieur to its single components in to placebo in terms of late astmatic response (LAR), when given after inhaled allergen challenge;Secondary Objective: The secundary objectives will be the assessment of study drugs on early astmatic response (EAR) airway hyperresponsiveness, induced sputum, differential celcount, inflammatory mediators in supernatant, fractional exhaled nitric oxid (FeNO), values and pattern of volatile organic compounds (VOC's) detected with electronic nose.;Primary end point(s): Primary efficacy variable will be the mean % change in FEV1 at LAR expressed as area under the curve (AUC). Secondary efficacy variables will be : - the mean % change in FEV1 at EAR; - maximum % fall in FEV1 from baseline at EAR and LAR; - changes in other spirometric indexes at EAR and LAR; - changes in airway hyper responsiveness; - changes in induced sputum cell count and inflammatory mediators in supernatant; - changes in FeNO; - change in VOCs pattern. | — |
Countries
Netherlands
Outcome results
None listed