Effect of Ciclesonide (320 µg/day) vs. Fluticasone Propionate (375 µg/day) vs. Placebo on Short-term Linear Growth Rate and HPA-axis Function in Prepubertal Children with Mild AsthmaA double-blind, double-dummy, placebo-controlled, randomized, 3 period cross-over study

Phase 1

• Conditions: asthma bronchiale; MedDRA version: 5.1Level: lltClassification code 10003553

• Registration Number: EUCTR2005-001386-34-DK
• Lead Sponsor: ALTANA Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-10
• Last Update Posted: 20 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

· Written informed consent by the patient’s parent(s) or legal guardian(s) and by the patient, if capable;
· Male or female outpatients aged 6 to 12 years;
· Prepubertal stage, i.e.:
- Females: breasts < or = Tanner stage I (1966)
- Males: testicular volume < or = 2 ml measured with a Prader orchidometer;
· Good health with the exception of asthma;
· History of asthma for at least 6 months as defined by ATS criteria (ATS, 1986);
· Currently (i.e. for at least 3 weeks prior to B0) using rescue medication only (i.e. of short acting beta-agonists or prn use of long acting inhaled beta-agonists, the latter for a maximum of 3 times per week);
· FEV1 > or = 80% predicted (measured at least 6 hours after the inhalation of a short acting beta-agonist or 10 hours after inhalation of a long acting inhaled beta-agonist);
· Stable clinical state (no asthma exacerbation or relevant respiratory tract infection within 4 weeks directly prior to B0);
· Ability to use the MDI with spacer correctly and reliably.

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

Diseases and health status:
· Birth weight below 2.5 kg;
· Childbearing potential (i.e. beyond menarche);
· Meeting criteria greater than Stage I in Tanner (1966);
· Known adrenal insufficiency/hypopituitarism;
· Concurrent diseases or conditions which may subsequently affect growth e.g. dysmorphic syndromes, skeletal dysplasias, rickets, protein energy malnutrition, psychosocial deprivation, endocrine conditions, constitutional delay in growth;
· COPD (i.e. chronic bronchitis or emphysema) and/or relevant lung diseases causing alternating impairment in lung function;
· Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation;
· Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e.g. active pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment);
· 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);
· Two or more hospitalizations for asthma within the last year or one hospitalization within the last 6 months directly prior to B0 (with the exception of hospitalization for diagnostic reasons);
· Current smoking

Medications:
· Use of orally inhaled steroids within the last 3 weeks prior to B0 and systemic steroids within the last 8 weeks prior to B0 (injectable depot steroid 12 weeks); use of orally inhaled steroids other than study medication or systemic steroids during the study (incl. washout periods);
· Use of other anti-asthmatic drugs (i.e. long-acting beta-agonists [regular use], oral beta-agonists, xanthines [e.g. theophylline], leukotriene antagonists, lipoxygenase inhibitors, orally inhaled sodium cromoglycate and nedocromil sodium, ketotifen) within the last 3 weeks directly prior to B0 and during the study (incl. washout periods);
· Use of nasal or ophthalmologic steroids and nasal anticholinergics as well as dermatological steroids during the study (incl. washout periods);
· Washout times of non allowed concomitant drugs cannot be adhered to;
· Known or suspected hypersensivity to inhaled steroids or to other excipients of the MDIs.

Common criteria:
· Informed consent cannot be obtained, since parent(s) or legal guardian(s) is/are, as judged by the investigator, mentally or legally incapacitated;
· Intention to relocate during the course of the study without possibility to further adhere to study visit schedule;
· Known or suspected non-compliance, alcohol or drug abuse;
· Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders;
· Previous enrollment into the current study;
· Participation in another study within 30 days preceding and during the present study.

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 effects of inhaled ciclesonide (320 µg/day, ex mouthpiece) vs. fluticasone propionate (375 µg/day, ex valve) vs. placebo on short-term linear growth and on HPA-axis function in prepubertal chil-dren with mild persistent asthma;Secondary Objective: Further data on safety and tolerability will be gathered. ;Primary end point(s): Variable of primary interest: <br>· Growth velocity of the right lower leg as measured by knemometry.<br><br>Secondary variables:<br>· HPA-axis function (overnight urine free cortisol);<br>· Weight and height;<br>· Lung function from spirometry (FEV1);<br>· Asthma symptom score, use of rescue medication from diary;<br>· Adverse events;<br>· Vital signs, including blood pressure, pulse rate;<br>· Physical examination;<br>· Laboratory investigation