A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler
NCT ID: NCT02148120
Last Updated: 2017-03-29
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
PHASE2
60 participants
INTERVENTIONAL
2014-04-30
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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CHF1535 NEXThaler 100/6, 1 puff
Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg
Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg
CHF1535 NEXThaler 100/6 µg, 4 puffs
Beclometasone Dipropionate 400 µg + Formoterol Fumarate 24 µg
Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg
CHF1535 NEXThaler 200/6 µg, 1 puff
Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
CHF1535 NEXThaler 200/6 µg, 4 puffs
Beclometasone Dipropionate 800 µg + Formoterol Fumarate 24 µg
Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
Placebo NEXThaler
Placebo
Placebo
Interventions
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Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg
Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female aged between 18 and 65 years inclusive;
* Evidence for "partially controlled" or "uncontrolled" asthma;
* Medium daily dose of previous inhaled corticosteroids (ICS) treatment;
* FEV1 between 60% and 85% of the predicted normal values;
* A documented positive response to the reversibility test;
* Non-smokers or ex-smokers;
* A cooperative attitude and ability to be trained in the proper use of a DPI.
Exclusion Criteria
* Significant seasonal variation in asthma occurring or expected to occur during study participation;
* History of near fatal asthma, brittle asthma, accident and Emergency treatment or 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;
* Diagnosis of Chronic Obstructive Pulmonary Disease;
* 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;
* Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids;
* Allergy, sensitivity or intolerance to study drugs or excipients;
* Patients who received any investigational drug within the last 8 weeks before the screening;
* Patients taking any of the non-permitted concomitant medication;
* Subjects unlikely to comply with the study protocol;
* Any clinically relevant abnormal value or physical finding at screening;
* Significant medical history;
* Abnormal and clinically significant 12-lead electrocardiogram;
* Patients with low compliance of QVAR intake.
18 Years
65 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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Hammersmith Medicines Research
London, , United Kingdom
Respiratory Clinical Trials, Hearth Lung Centre
London, , United Kingdom
Medicines Evaluation Unit
Manchester, , United Kingdom
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-01535BA1-01
Identifier Type: -
Identifier Source: org_study_id
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