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Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Asthma

Treatments

Drug: Ciclesonide (XRP1526)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00174720
EFC6164
XRP1526B/3031

Details and patient eligibility

About

To investigate the efficacy of ciclesonide MDI either as once daily or twice daily in patients with mild to moderate asthma, who have not previously been treated with an inhaled corticosteroid.

Enrollment

708 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males or females 12 years or older
  • History of persistent bronchial asthma for at least 6 months
  • Documented use of bronchodilators (short acting only) only or methylxanthines for at least 1 month before screening
  • At screening, FEV1 60 to 90% of predicted. Reversibility of FEV1 by at least 12% 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 6 months before screening. Use of inhaled steroids within 30 days before screening. 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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