Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Formoterol Fumarate

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.