An open, randomised, parallel group, multicentre study to compare the efficacyand safety of FlutiForm pMDI vs Seretide pMDI in paediatric subjects withmild to moderate persistent, reversible asthma.
- Conditions
- MedDRA version: 8.1Level: LLTClassification code 10003555Term: Asthma bronchialAsthma bronchial
- Registration Number
- EUCTR2006-005928-16-CZ
- Lead Sponsor
- Mundipharma Research Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1. Male or female subjects between 4-12 years of age. Female subjects must be pre-menarche to be eligible.
2. Known history of mild to moderate persistent asthma for at least 6 months prior to the screening visit. Subjects with mild asthma must, in the investigator’s opinion, require the use of a long acting beta2-agonist.
3. Demonstrate a FEV1 of 60% to 100% of predicted normal values (Zapletal et al., 1977) during the screening phase following appropriate withholding of asthma medications (if applicable).
- No beta2-agonist use on day of screening.
- No use of inhaled combination asthma therapy on day of screening.
- Inhaled corticosteroids are allowed on day of screening.
4. Documented reversibility of at least 15% in FEV1 during the screening phase.
5. Demonstrate satisfactory technique in the use of the pressurised Metered Dose Inhaler (pMDI) and spacer device.
6. Willing and able to enter information in the electronic diary (parental help is acceptable) and attend all study visits.
7. Willing and able to substitute study medication for their pre study prescribed asthma medication for the duration of the study.
8. Written informed consent obtained from the parent(s)/ legal representative, and where possible informed assent from the subject (for a definition of legal representative” see national laws).
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
1. Near fatal or life-threatening (including intubation) asthma within the past year.
2. Hospitalisation or an emergency visit due to asthma in the 4 weeks before the Screening Visit.
3. History of systemic (injectable) corticosteroid medication within 1 month before the Screening Visit.
4. History of leukotriene receptor antagonist use, e.g. montelukast, within the past week.
5. Current evidence or history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, or cardiac dysrhythmia. ‘Clinically significant’ is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.
6. In the investigator’s opinion, a clinically relevant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.
7. Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
8. Known Human Immunodeficiency Virus (HIV)-positive status.
9. Current smoking history within 12 months prior to the Screening Visit.
10. Current evidence or history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.
11. Subjects who have taken beta-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past week.
12. Current use of medications that will have an effect on bronchospasm and/or pulmonary function.
13. Current evidence or history of hypersensitivity or idiosyncratic reaction to test medications or components.
14. Receipt of an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).
15. Current participation in a clinical study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to show comparable efficacy of FlutiForm with Seretide based on mean Forced Expiratory Volume in the 1st second (FEV1) values.;Secondary Objective: Secondary objectives of the study are to compare peak expiratory flow rates (PEFR) and other lung function parameters, time to onset of action, amount of rescue medication use, asthma symptom scores, sleep disturbance due to asthma, amount of daily oral or parenteral corticosteroid dose, exacerbations (requiring<br>oral/parenteral steroid use, medical intervention), subject acceptance, and spontaneously reported adverse events.<br>Another secondary objective is to monitor the long term safety of FlutiForm during the extension phase based on the assessment of growth and plasma cortisol levels.;Primary end point(s): To compare the efficacy and safety of FlutiForm, measured by Forced Expiratory Volume in the 1st second (FEV1).
- Secondary Outcome Measures
Name Time Method