CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,121 enrolled
Drug / intervention
Ciclesonide +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • Age ≥18 years
  • Asthma diagnosis for ≥6 months
  • Clinically stable asthma at enrollment
  • Requires ICS treatment per Canadian Asthma Consensus Guidelines
Key exclusion· 7
  • On combination therapy (ICS + LABA) in past 3 months or requires it
  • Severe asthma
  • Asthma exacerbation in past 3 months requiring hospitalization or ER visit
  • Systemic steroids >3 times in past 6 months or currently using systemic steroids

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

Search/NCT00404547
NCT00404547Phase 4Completed

An Open-Label Randomized, Multicenter Study in Patients With Asthma to Evaluate the Effectiveness of Alvesco® (Ciclesonide) Compared to Asthma Usual Care in a Primary Practice Setting

AstraZeneca·interventional·Posted Nov 28, 2006·Updated Feb 1, 2017

In Brief

A Phase 4 clinical trial evaluating Ciclesonide and Usual Care Inhaled Glucocorticosteroids for Asthma. Completed, enrolled 1,121 participants across 186 sites.

Detailed Summary

The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide) compared with usual asthma care in the primary care setting. Patients with a history of asthma for at least 6 months and who, in the opinion of the physician, meet the clinical requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either receive Alvesco® or usual care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 28, 2006
Enrollment StartNov 1, 2006
Primary CompletionApr 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.6 years ago

Interventions

Ciclesonidedrug

Asthma Care with Alvesco

Usual Care Inhaled Glucocorticosteroidsdrug

Usual asthma care and dosage as chosen by the Primary Care Physician including inhaled steroid treatment