Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled Corticosteroid

Phase 3 Completed 456 enrolled Sanofi

RandomizedParallel-groupDouble-blindTreatment

Summary

To investigate the efficacy of ciclesonide MDI either as once daily or a twice daily regimen in patients with mild to moderate asthma, who have previously been treated with an inhaled corticosteroid.

Timeline

Start: 2005-07
Primary completion: 2006-02
Completion: 2006-02

Outcome

Met primary endpoint

paper FEV(1) declined from baseline after placebo (-0.12 L; p < 0.0001) and significantly versus CIC treatments (p < 0.001). PMID 19549431 ↗

Publications

Meltzer EO, Korenblat PE, Weinstein SF, Noonan M, Karafilidis J. Efficacy and safety evaluation of ciclesonide in mild-to-moderate persistent asthma previously treated with inhaled corticosteroids. Allergy Asthma Proc. 2009 May-Jun;30(3):293-303. doi: 10.2500/aap.2009.30.3241.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ciclesonide	Other / unclassified	80 ug	Inhaled
Subject	Ciclesonide	Other / unclassified	160 ug	Inhaled