NCT01803087 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Kuna P, Govoni M, Lucci G, Scuri M, Acerbi D, Stelmach I
Pharmacokinetics and pharmacodynamics of an extrafine fixed pMDI combination of beclometasone dipropionate/formoterol fumarate in adolescent asthma. Br J Clin Pharmacol. 2015 Sep;80(3):569-80. doi:

A SINGLE-DOSE, OPEN LABEL, RANDOMIZED, 3-WAY CROSSOVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 100/6 pMDI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg) WITH OR WITHOUT SPACER DEVICE VERSUS THE FREE COMBINATION OF LICENSED BECLOMETHASONE pMDI AND FORMOTEROL pMDI IN ASTHMATIC ADOLESCENT PATIENTS AND ONE OPEN ARM FOR ADULT PATIENTS AS CONTROL GROUP TREATED WITH CHF 1535 100/6 pMDI.

Details for clinical trial NCT01803087

Clinical trial NCT01803087 - References