Clinical trial NCT00868023: Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients
Official title: A Phase II, Multinational, Multicentre, Double Blind, Double Dummy, Randomised, 5-way Cross-over, Placebo and Active Controlled Clinical Study to Test the Non-inferiority of a Single Dose of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg Dry Powder) Via NEXT™ DPI 1 or 4 Inhalations Versus CHF 1535 (Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg) pMDI With HFA-134a Propellant 1 or 4 Puffs on FEV1 AUC0-12h in Partly Controlled Adult Asthmatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2009-03-24
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over

Detailed description: To demonstrate the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT DPI and CHF 1535 via HFA-134a "extrafine" pMDI in partly controlled adult asthmatic patients

Eligibility criteria: Inclusion Criteria:

* Patient's written informed consent obtained prior to any study-related procedures.
* Outpatient male or female aged ≥ 18 years.
* Evidence for "partly controlled" asthma in the 2 weeks before the screening visit
* Under previous inhaled corticosteroids (ICS) treatment at the screening visit
* Forced expiratory volume in the first second (FEV1) ≥ 60% and ≤ 90% of the predicted normal values at the screening visit.
* A documented positive response to the reversibility test at the screening visit, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, 30 minutes after 400 μg salbutamol pMDI
* Patients free of long-acting beta2-agonists (LABAs) treatment for at least 2 weeks before the screening visit.
* Patients free of short-acting beta2-agonists (SABAs) treatment for at least 6 hours before the screening visit.
* Non-smokers or ex-smokers

Exclusion Criteria:

* Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they are menopausal or are using effective and acceptable methods of contraception.
* Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
* History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit) within 1 year before screening.
* Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit.
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
* Diagnosis of restrictive lung disease.
* Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
* Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
* Allergy, sensitivity or intolerance to study drugs or excipients.
* Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality.

Primary outcomes:
measure: FEV1 AUC0-12h
timeFrame: Every week
Secondary outcomes:
measure: FVC as assessed at the same time points as for FEV1; Peak FEV1 in terms of absolute values and % of change from baseline Safety evaluation
timeFrame: Every week
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Pr DS SINGH
Study officials:
affiliation: Medecines Evaluation Unit - Southmoor Road - M23 9QZ Manchester - UK
name: David Singh, Professor
role: PRINCIPAL_INVESTIGATOR
References: