| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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 Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 8.1 |
| E.1.2 | Level | Pt |
| E.1.2 | Classification code | 10003553 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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 ®).
|
|
| E.2.2 | Secondary objectives of the trial | |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal 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. |
|
| E.4 | Principal 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.
|
|
| E.5 End points |
| E.5.1 | 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
|
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | Yes |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 7 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 7 |
Print
