A comparative study of inhaled ciclesonide versus placebo in children with asthma (RAINBOW) - RAINBOW

ycomed GmbH0 sites1,050 target enrollmentJune 19, 2006

Overview

No summary available.

Registry

who.int

Start Date

June 19, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ycomed GmbH

•\- Male or female outpatients aged 6 to 11 years,
•\- History of persistent bronchial asthma (as defined by GINA 2004 criteria) for at least 6 months,
•\- Ability to perform reproducible pulmonary function tests,
•\- Ability to show optimal use of MDI, including inhalation technique,
•\- Either treatment with rescue medication prn only or treatment with ICS (not exceeding 200 µg/d fluticasone propionate \[FP] or equivalent), or treatment with a non\-ICS controller drug (e.g., cromones, xanthines, leukotriene antagonists, lipoxygenase inhibitors. or inhaled long\-acting ß2\-agonists \[LABA]), respectively, at a constant dose over the last 30 days directly prior to B0,
•\- PEF (% of predicted value) measured by spirometry at least 4 hours after inhalation of rescue medication (e.g. a short\-acting ß2\-agonist \[SABA]), and at least 24 hours after the use of LABA, xanthines, or oral bronchodilators:
•\- 40% \- 90% for patients using rescue medication only,
•\- 50% \- 100% for patients using ICS,
•\- 50% \- 100% for patients using non\-ICS controller drugs.
•Are the trial subjects under 18? yes

•The presence of any one of the following will cause exclusion of the patient:
•a) Diseases and health status:
•\- Concomitant severe diseases,
•\- Diseases which are contraindications for the use of ICS (e. g. active or inactive pulmonary tuberculosis, or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment),
•\- Chronic obstructive pulmonary disease (COPD; i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function,
•\- Respiratory tract infection or asthma exacerbation within the last 30 days prior to B0 as well as during baseline,
•\- Two or more inpatient hospitalizations for asthma within the last year (with the exception of hospitalizations for diagnostic reasons),
•\- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation,
•\- History of life\-threatening asthma (i.e. prior intubation for asthma and/or respiratory arrest, anoxic seizures, significant hypercarbia in the setting of an asthma exacerbation),
•\- Premature birth (i.e. \< 36 weeks gestation),