CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 528 enrolled
Drug / intervention
Ciclesonide +2 moredrug
Likely dose
Ciclesonide MDI 40 µg or 80 µg twice daily for 12 weeksAI-extracted
Key inclusion· 4
  • ✓History of persistent bronchial asthma for at least 3 months prior to screening
  • ✓If on controller therapy, must be documented use of inhaled steroid or Singulair 5 mg once daily; if not on controller therapy, may have documented reliever use or be untreated
  • ✓Morning Peak Expiratory Flow (AM PEF) ≤90% of predicted values after 6-hour withhold of albuterol/salbutamol
  • ✓For patients aged 6 to <12 years: FEV1 ≥50% to ≤85% of predicted normal after 6-hour withhold of albuterol/salbutamol
Key exclusion· 6
  • ✕Nocturnal awakenings requiring albuterol/salbutamol treatment on 4 or more nights of the last 7 days during screening
  • ✕Use of >8 puffs/day of albuterol/salbutamol on 3 or more consecutive days within the last 7 days
  • ✕Upper or lower respiratory tract infection within 4 weeks prior to screening or during screening period
  • ✕History of life-threatening asthma, including significant hypercarbia (pCO2 >45 mmHg), prior intubation, respiratory arrest, or seizures from asthma exacerbation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00392288
NCT00392288Phase 3Completed
CompareCT.gov

A Multicenter, Multi-national, Randomized, Double-blind, Placebo-controlled, Study to Assess the Efficacy and Safety of Ciclesonide Metered-dose Inhaler (MDI) at 80 μg BID or 40 μg BID for 12 Weeks in Patients Aged 4 to <12 Years With Persistent Asthma.

AstraZeneca·interventional·Posted Oct 25, 2006·Updated Feb 1, 2017

In Brief

A Phase 3 clinical trial evaluating Ciclesonide and Placebo for Asthma. Completed, enrolled 528 participants across 6 sites in 6 countries.

Detailed Summary

Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma. Secondary objective: To assess the safety and tolerability of ciclesonide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesHungary, Mexico, Poland, Russia, South Africa, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2006
Enrollment StartSep 1, 2006
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.7 years ago

Interventions

Ciclesonidedrug

Ciclesonide MDI 40 µg BID over twelve weeks

Ciclesonidedrug

Ciclesonide MDI 80 µg BID over twelve weeks

Placebodrug

Placebo MDI over twelve weeks