Status:
COMPLETED
A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding d...
Eligibility Criteria
Inclusion
- Written informed consent
- Outpatients of both sexes, aged \> 12 years
- Moderate to severe symptomatic asthma
- Forced expiratory volume in the first second (FEV1) \> 40% and \< 80% of the predicted normal values
- Reversibility test
- "Partly controlled" asthma (GINA revised 2006)
- Patients free of long-acting beta2-agonists (LABAs) treatment
- Under inhaled corticosteroids (ICS) treatment
- A minimum inspiratory flow ≥ 40 L/min 10.
- Non-smokers or ex smokers
- Asthma Control Questionnaire ACQ score ≥ 1.5
Exclusion
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, UNLESS they are menopausal or have 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
- Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit
- Diagnosis 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 2 months (3 months for parenteral depot corticosteroids)
- Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids
- Allergy to any component of the study treatments
- Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit
- Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ;
- Patients with abnormal QTc
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
783 Patients enrolled
Trial Details
Trial ID
NCT00862394
Start Date
February 1 2009
End Date
January 1 2010
Last Update
April 13 2018
Active Locations (1)
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1
Oliver Kornmann - National Coordinator in Germany
Mainz, Germany, 55131