A phase III, Randomised, Double-blind, Double-dummy, placebo controlled crossover study to compare the systemic effects of inhaled combination Fluticasone propionate 250ug and Salmeterol xinafoate 50 ug versus the reference Fluticasone propionate 250ug and Salmeterol xinafoate 50 ug inhaler on short-term linear growth and on HPA-axis function in pre-pupertal children with minl asthma

eolab Ltd0 sites30 target enrollmentStarted: January 25, 2006Last updated: March 19, 2012

Conditions

Drugs

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor
Enrollment: 30

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•1.Written informed consent by the patient’s parents or legal guardians.
•2.Female outpatients aged 6 to 11 years, or male outpatients aged 6 to 12 years.
•3.Pre-pubertal stage, i.e.:
•a.Females: breasts < Tanner stage I.
•b.Males: testicular volume < 2 ml measured with a Prader orchidometer.
•4.Good health with the exception of asthma.
•5.History of mild asthma for at least 6 months as defined by ATS criteria.
•6.Currently (i.e. for at least 3 weeks) using inhaled short acting beta-agonists and/or prn use of long acting inhaled beta-agonists, the latter of a maximum of 5 times per week.
•7.FEV1 > 80% predicted (measured at least 6 hours after the inhalation of a short acting beta-agonist or after 10 hours after inhalation of a long acting inhaled beta-agonist).
•8.Stable clinical state (no asthma exacerbation or relevant respiratory tract infection within 4 weeks directly prior to B0);
•9.Ability to use the inhalers 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

•1. Patients who have had their first menstruation and are sexually active.
•2. Contraindication to or known or suspected hypersensitivity to fluticasone propionate, salmeterol xinafoate, or any other constituents of the investigational products.
•3. Exceeding Stage I of Tanner criteria (1966).
•4. Known adrenal insufficiency/hypopituitarism.
•5. Concurrent diseases or conditions which may subsequently effect growth e.g. dysmorphic syndromes, skeletal dysplasias, rickets, protein energy malnutrition, psychosocial deprivation, endocrine conditions, constitutional delay in growth.
•6. COPD (i.e. chronic bronchitis or emphysema) and/or relevant lung diseases causing alternating impairment in lung function.
•7. 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).
•8. Concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, haematological, neurological, immunological).
•9. 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).
•10. Two or more hospitalizations for asthma within the last year or one hospitalization overnight within the last 6 months directly prior to B0 (with the exception of hospitalization for diagnostic reasons).
•11. Acute upper or lower respiratory tract infections within 4 weeks of the screening visit.
•12. Current smoking.
•13. Any change in asthma therapy within 4 weeks preceding the screening visit.
•14. 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) and during the study (incl. washout periods).
•15. Use of nasal or ophthalmologic or dermatological steroids during the study (incl. washout periods).
•16. Informed consent cannot be obtained, since parent(s) or legal guardian(s) are, as judged by the Investigator, mentally or legally incapacitated.
•17. Intention to relocate or move away during the course of the study without the possibility of adhering to the study visit schedule.
•18. In the Investigator’s opinion, patients or parents unlikely to comply with study procedures, for example, due to language problems or psychological disorders.

Investigators

Sponsor

eolab Ltd

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