Mild asthma in pre-pubertal children. MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: Fluticasone Propionate 50 MCG HFA MDI
Pharmaceutical Form: Inhalation vapour, solution
Pharmaceutical form of the placebo: Inhalation vapour, solution
Route of administration of the plac
Sponsors
Neolab Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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. Other orally administered bronchodilators, theophylline, leukotriene antagonists, lipoxygenase inhibitors, cromones or ketotifen, are permitted but the dosage must be maintained constant throughout the study. 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 within 4 weeks directly prior to T0); 9. Ability to use the inhalers correctly and reliably. 10. Patients may be considered for re-admission after a four week recovery period, if they had been withdrawn previously from the study for incidental events (eg URTI) not related to safety issues. 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
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, 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. Other 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 T0 (with the exception of hospitalization for diagnostic reasons). 11. Current smoking. 12. Any change in asthma therapy within 4 weeks preceding the screening visit. 13. Use of inhaled steroids within the last 3 weeks prior to T0 and systemic steroids within the last 8 weeks prior to T0 (injectable depot steroid 12 weeks) and during the study (incl. washout periods). 14. Use of nasal or ophthalmologic or dermatological steroids during the study (incl. washout periods). 15. Informed consent cannot be obtained, since parent(s) or legal guardian(s) are, as judged by the Investigator, mentally or legally incapacitated. 16. Intention to relocate or move away during the course of the study without the possibility of adhering to the study visit schedule. 17. In the Investigator’s opinion, patients or parents unlikely to comply with study procedures, for example, due to language problems or psychological disorders. 18. Known or suspected non-compliance, alcohol or drug abuse. 19. Previous completed participation in the current study. 20. Treatment with any investigational drug in the 3 months preceding the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show that the test inhaled fluticasone (plus Volumatic spacer) has a non-inferior effect on short-term linear growth in pre-pubertal children with asthma as compared to a reference fluticasone inhaler (Flixotide Evohaler ®) plus Volumatic spacer. Primary variable: • Growth velocity of the right lower leg as measured by knemometry. ;Secondary Objective: Secondary variables: • HPA-axis function (overnight urinary free cortisol); • Lung function from spirometry (FEV1); • Use of rescue medication from diary. • FENO ;Primary end point(s): Growth velocity of the right lower leg as measured by knemometry. | — |
Countries
Denmark
Outcome results
None listed