NCT01349257 - 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)

Govoni M, Piccinno A, Lucci G, Poli G, Acerbi D, Baronio R, Singh D, Kuna P, Chawes BL, Bisgaard H
The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size. Pulm Pharmacol Ther. 2015 F

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.

Details for clinical trial NCT01349257

Clinical trial NCT01349257 - References