Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role. The chronic inflammation causes an associated increase in airway hyper-responsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning. These episodes are usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with treatment . MedDRA
Conditions
Interventions
Trade Name: Seratide, Diskos® (dry powder inhaler) containing fluticasone propionate 250 µg and salmeterol xinafoate 50 µg per dose
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Fluticas
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show that the test inhaled fluticasone plus salmeterol (Neolab “Multihaler”) has a non-inferior effect on short-term linear growth in pre-pubertal children with asthma as compared to a reference combination fluticasone and salmeterol inhaler (Seretide Accuhaler ®). ;Secondary Objective: ;Primary end point(s): Primary variable: • Growth velocity of the right lower leg as measured by knemometry. Secondary variables: • HPA-axis function (overnight urinary free cortisol); • Lung function from spirometry (FEV1); • Use of rescue medication from diary. • FENO | — |
Countries
Denmark
Outcome results
None listed