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Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.

NCT00392288 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2017-02-01

Study results available
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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.

Conditions

Interventions

DRUG

Ciclesonide

Ciclesonide MDI 40 µg BID over twelve weeks

DRUG

Ciclesonide

Ciclesonide MDI 80 µg BID over twelve weeks

DRUG

Placebo

Placebo MDI over twelve weeks

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca AstraZeneca · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States
  • Hungary
  • Mexico
  • Poland
  • Russia
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00392288 on ClinicalTrials.gov