EUCTR2005-001386-34-DK
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- asthma bronchiale
- Sponsor
- ALTANA Pharma AG
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\);
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);
Outcomes
Primary Outcomes
Not specified
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