drugset / Trial / NCT01343745

Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI)

NCT01343745

Phase 2 Completed 18 enrolled Chiesi Farmaceutici S.p.A.
RandomizedCrossoverTriple-blindTreatment

Summary

The aim of this exploratory investigation is to evaluate if the Forced Expiratory Volume in the 1st second (FEV1) measurements, fractional exhaled nitric oxide (FENO) and Provocative Concentration 20 (PC20) after Adenosine Monophosphate (AMP) bronchial challenge evaluated after administration of a fixed combination of a Long-acting Beta-2-agonist (LABA) and an Inhaled Corticosteroid (ICS) at increasing doses may be suitable to demonstrate a dose response.

Timeline

Start
2008-02
Primary completion
2008-08
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Formoterol Other / unclassified 6 ug Inhaled
Subject Formoterol Other / unclassified 24 ug Inhaled
Subject beclomethasone dipropionate Other / unclassified 100 ug Inhaled
Subject beclomethasone dipropionate Other / unclassified 400 ug Inhaled

Indications