Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder
NCT ID: NCT01738087
Last Updated: 2021-10-29
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
30 participants
INTERVENTIONAL
2012-11-30
2013-01-31
Brief Summary
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At the same time, the study will assess if the lung deposition and the total systemic exposure to Formoterol is affected by increasing doses of BDP.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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NEXThaler 100/6 mcg DPI
Single dose (4 inhalations)of NEXThaler 100/6 mcg DPI: total dose 400/24 mcg
NEXThaler 100/6 mcg DPI
NEXThaler 200/6 mcg DPI
Single dose (4 inhalations)of NEXThaler 200/6 mcg DPI: total dose: 800/24 mcg
NEXThaler 200/6 mcg DPI
NEXThaler placebo
Single dose (4 inhalations)
NEXThaler placebo
Placebo comparator
NEXThaler 100/6 mcg plus CB
Single dose (4 inhalations) NEXThaler 100/6 mcg administered with activated charcoal (Charcoal Block): total dose 400/24 mcg
NEXThaler 100/6 mcg DPI
NEXThaler 200/6 mcg plus CB
Single dose (4 inhalations) NEXThaler 200/6 mcg administered with activated charcoal (Charcoal Block): total dose 800/24 mcg
NEXThaler 200/6 mcg DPI
Flixotide Accuhaler 500 mcg
Single dose (2 inhalations) of fluticasone propionate
Flixotide Accuhaler 500 mcg
Active comparator
Interventions
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NEXThaler 100/6 mcg DPI
Flixotide Accuhaler 500 mcg
Active comparator
NEXThaler 200/6 mcg DPI
NEXThaler placebo
Placebo comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Asthmatic patients already treated with low daily doses of Inhaled Corticosteroids (ICS) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ICS/Long Acting Beta2 Agonists (LABA) fixed combinations.
* Patients with Forced Expiratory Volume in 1 sec (FEV1) \>= 70 % of predicted values
* Non or ex-smokers
* Body Mass Index (BMI) \>= 18.5 and \<= 32 kg/m2
Exclusion Criteria
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* History of near fatal asthma
* Patients with abnormal QTcF at screening Visit
* Hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
* Lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period.
* History of drug addiction or excessive use of alcohol ;
* Diagnosis of restrictive lung disease.
* Patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids)
* Significant medical history or any laboratory abnormality indicative of a significant underlying condition
18 Years
70 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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The Medicine 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
CSR Synopsis available in the CHIESI Clinical Study Register
Other Identifiers
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2012-002370-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD-1205-PR-0087
Identifier Type: -
Identifier Source: org_study_id