NCT01471340 - 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)

Weinstein CLJ, Ryan N, Shekar T, Gates D, Lane SJ, Agache I, Nathan RA; SPIRO Investigators
Serious asthma events with mometasone furoate plus formoterol compared with mometasone furoate. J Allergy Clin Immunol. 2019 Apr;143(4):1395-1402. doi: 10.1016/j.

A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 Also Known as P202)

Details for clinical trial NCT01471340

Clinical trial NCT01471340 - References