drugset / Trial / NCT01343745
Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |