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Dose Response Study of Inhaled Ciclesonide (Glucocorticosteroid) to Patients With Persistent Asthma

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: September 13, 2005
Last updated: April 7, 2009
Last verified: April 2009
To investigate the efficacy and safety of ciclesonide inhaled into the lungs in a range of doses in a new dry powder inhaler compared to ciclesonide inhaled into the lungs using a metered dose inhaler

Condition Intervention Phase
Drug: AVE2635A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo- and Active-Controlled (Ciclesonide Metered-Dose Inhaler), Randomized, Parallel-Group, Dose-Range Finding Study of Ciclesonide Administered by Dry Powder Inhaler (Ultrahaler) in Adult and Adolescent Patients With Persistent Asthma

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Primary endpoint will be the change from baseline to week 6 in FEV1

Secondary Outcome Measures:
  • PK parameters measured after 4 weeks of treatment. Change from baseline in serum cortisol pre-and post ACTH stimulation, AM and PM peak expiratory flow rates, AM and PM asthma symptoms, and albuterol use after 6 weeks of treatment.

Enrollment: 1145
Study Start Date: March 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 for at least 1 month before screening; At screening, FEV1 40% or more of predicted normal and at randomization, FEV1 between 40 and 80% predicted normal; 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; Treatment with any investigational product within 30 days prior to study entry
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Please refer to this study by its identifier: NCT00174746

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00174746     History of Changes
Other Study ID Numbers: DFI6153
Study First Received: September 13, 2005
Last Updated: April 7, 2009

Keywords provided by Sanofi:
Glucocorticosteroid; Dose response; Bronchospasm

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents processed this record on April 28, 2017