Pharmacokinetic Clinical Study of CHF1535 NEXT DPI® Versus CHF1535 pMDI
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|ClinicalTrials.gov Identifier: NCT01349257|
Recruitment Status : Completed
First Posted : May 6, 2011
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: BDP/Formoterol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study Title: A Single-dose, Open-label, Randomised, 2-way Crossover, Clinical Pharmacology Study of Four Inhalations of CHF 1535 100/6 NEXT DPI® (Fixed Combination of Beclomethasone Diproponate 100 µg Plus Formoterol Fumarate 6 µg) Versus the Same Dose of CHF 1535 100/6 pMDI Both Administered With Charcoal Block.|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
- lung bioavailability [ Time Frame: 13 times/24hr ]To compare the lung bioavailability of B17MP (active metabolite of BDP) and formoterol after four inhalations using the new Chiesi dry powder inhaler vs pMDI using spacer device, with activated Charcoal Block.
- To assess the safety and the tolerability of the study treatments considering AE and measuring vitals signs as blood pressure and heart rate in the specified time frame. [ Time Frame: 13 times/24hr ]Adverse events and Vital signs: blood pressure and heart rate assessed at pre-dose and 30 min, 1, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349257
|Medicines Evaluation Unit Ltd|
|Manchester, United Kingdom, M23 9QZ|
|Principal Investigator:||Dave Singh, MD||Medicines Evaluation Unit Ltd, Manchester, United Kingdom|