Effect of low dose continuous treatment with Ciclesonide over one year on the time to first exacerbation in children with mild asthma versus intermittent treatment for exacerbations - POPCICLE

Phase 1

• Conditions: Asthma bronchial; MedDRA version: 9.1Level: LLTClassification code 10003555Term: Asthma bronchial

• Registration Number: EUCTR2007-003736-34-HU
• Lead Sponsor: ycomed Canada Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-10
• Study Completion: 2009-06-25
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

· Patients giving assent and parents/guardians informed consent
· Outpatients, male or female, age 4 to 11 years inclusive
· Symptoms consistent with the diagnosis of asthma for at least 12 months not requiring the use of an ICS (less or equal to 250mg/day FP or equivalent) for more than 8 weeks within the last 12 months (no ICS 30 days prior to B0)
· FEV1 at least 80 % of predicted, measured at least 4 hours after the inhalation of short acting b2-agonist (e.g. salbutamol), or at least 24 hours after the inhalation of a LABA (salmeterol or formoterol), anticholinergics or the oral intake of theophylline or leukotriene antagonists
· Ability to perform reproducible lung function tests
· With the exception of asthma, are in good health
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· History of life-threatening asthma
· Hospitalization for asthma within the past 3 months or > or = 2 hospitalizations within the last year.
· Asthma exacerbation, or relevant RTI within the last 30 days requiring anti-asthmatic medication beyond an increase in bronchodilator dose
· Initiation of immunotherapy within 6 months of B0, or planned initiation within the study period
· Severe atopic dermatitis
· Concomitant severe diseases or diseases which are contraindicated for the use of ICS
· Relevant lung diseases causing alternating impairment in lung function
· Prematurely born children (< 36 weeks of gestation)
· Conditions [cardiovascular, neurological, hepatic, renal, respiratory (other than asthma or allergic rhinitis), or others] considered as clinically significant
· History of cataracts and/or glaucoma
· Suspected hypersensitivity to ICS or short-acting ß agonist
· Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
· Use of systemic corticosteriods for > 30 days within the previous year, or within 30 days (injectable depot steriods 6 weeks) of B0 or more than 3 times during the last 6 months
· Use of drugs not allowed or washout times of drugs cannot be adhered to
· Need for concomitant medications that interfere with the study
· Lung disease other than asthma, concomitant severe disease
· Smokers
· Pregnancy, intention to become pregnant during the trial or lack of safe contraception in females of child-bearing potential
· Patients who are mentally incapacitated
· Suspected non-compliance or inability to follow the procedures of the study
· Participation in another trial within 30 days of enrolment, or previous enrolment in current study
· Patient or parents relocation during the study, preventing adherence to visit schedule
· Parents or legal representative are, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To study and compare the efficacy of 2 dose levels of continuous (daily) inhalations of Ciclesonide versus placebo inhalation in addition to episodic treatment for exacerbations with regards to time to first exacerbation (episodic treatment is defined as the step-wise use of inhaled and oral corticosteroids);Secondary Objective: - To determine the effect of the different treatments on growth velocity<br>- To study and compare the effects of the 3 different treatment arms on the rate of exacerbations over the 1 year treatment phase, on the duration of exacerbations, on pulmonary function, asthma symptoms, use of rescue medication, quality of life, and days of school / work missed<br>- To study and compare the safety and tolerability of the three different treatment arms.;Primary end point(s): Time to first asthma exacerbation