NCT00174733

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
456

participants targeted

Target at P50-P75 for phase_3 asthma

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_3 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

April 8, 2009

Status Verified

April 1, 2009

Enrollment Period

7 months

First QC Date

September 13, 2005

Last Update Submit

April 7, 2009

Conditions

Asthma

Keywords

Glucocorticosteroid. Bronchospasm

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to Week 12 in FEV1

Secondary Outcomes (1)

  • Symptom scores, rescue albuterol use and morning peak flow measurements

Interventions

Ciclesonide (XRP1526)DRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females 12 years or older
  • History of persistent bronchial asthma for at least 6 months
  • Documented use of an inhaled steroid or a combination of an inhaled steroid/long-acting beta 2 agonist for at least 1 month before screening
  • At screening, FEV1 of 60 to 90% predicted or 70 to 95% predicted for either ICS or ICS/LABA use respectively.Reversibility of FEV1 by at least 12% and 200 ml post-bronchodilator
  • Be able to use oral inhalers
  • Non-smokers

You may not qualify if:

  • History of life-threatening asthma
  • Other pulmonary diseases; URI within 4 weeks before screening
  • Use of systemic steroids within 1 month before screening or more than 3 times in previous 6 months
  • Beta-adrenergic blocking agent use
  • More than 2 in-patient hospitalizations or ER visits due to asthma exacerbations in the prior year before screening
  • Pregnant or breast-feeding females
  • Females of child-bearing potential not using adequate means of birth control
  • Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease
  • Abnormal clinical laboratory parameters that would limit participation in the study or interfere with interpretation of study results
  • History of drug or alcohol abuse
  • Treatment with any investigational product within 30 days prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

Related Publications (1)

  • 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.

    PMID: 19549431DERIVED

MeSH Terms

Conditions

Asthma

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

July 1, 2005

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

April 8, 2009

Record last verified: 2009-04

Locations

US(1)