Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients
Study Identifier:
CCD-0809-PR-0038
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Asthma
Study Drug
- Drug: CHF 1535 Next DPI
- Drug: Foster BDP/Formoterol
- Drug: Placebo
Date
Feb 2009 - Jul 2009
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion 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.
Healthy Volunteers
No
Protocol Summary
Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over
Study Locations
Location
Status
Location
Pr DS SINGH
Manchester, United Kingdom, M23 9QZ
Status
N/A