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

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy of Ciclesonide Metered-Dose Inhaler at a Daily Dose of 160 μg Administered for Twelve Weeks Either in a Once-Daily Regimen in the Morning (160 μg qd AM) or in a Twice Daily Regimen (80 μg Bid) in Adults and Adolescents With Mild to Moderate Persistent Asthma Treated Previously With Inhaled Corticosteroids

NCT00174733•Sanofi

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
+1 more criteria

Locations (1)

Sanofi-Aventis

Bridgewater, New Jersey, United States

Key Dates

Start Date

July 1, 2005

Primary Completion Date

February 1, 2006

Completion Date

February 1, 2006

Last Updated

April 8, 2009

Enrollment

456

ACTUAL participants

Conditions

Asthma

Interventions

Ciclesonide (XRP1526)

DRUG

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Asthma

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RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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Asthma

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma