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
NCT ID: NCT00862394
Last Updated: 2018-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
783 participants
INTERVENTIONAL
2009-02-28
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
CHF 1535 Next DPI : BDP/Formoterol : 200/12 µg
BDP/Formoterol Next DPI
BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)
2
CHF 1535 HFA pMDI : BDP/Formoterol : 200/12 µg
Foster
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)
3
CHF 1535 Next DPI : BDP/Formoterol : 400/24 µg
BDP/Formoterol Next DPI
BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)
4
CHF 1535 HFA pMDI : BDP/Formoterol : 400/24 µg
Foster
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)
Interventions
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BDP/Formoterol Next DPI
BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)
Foster
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)
BDP/Formoterol Next DPI
BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)
Foster
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
12 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Locations
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Oliver Kornmann - National Coordinator in Germany
Mainz, , Germany
Countries
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Related Links
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Study Record on EU Clinical Trials Register including results
Other Identifiers
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CCD-0705-PR-0027
Identifier Type: -
Identifier Source: org_study_id
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