A single-centre, open-label, randomised, 2-way cross-over study to determine the effects on the short-term lower leg growth rate between Qvar® 100 µg bd delivered via a metered dose inhaler (MDI) (TEVA UK Ltd) with a reference beclometasone formulation via a reference MDI in children with mild to moderate asthma

• Conditions: Short-term lower leg growth rate in children with documented mild to moderate asthma.; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2007-007455-14-DK
• Lead Sponsor: TEVA UK Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-08
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male and female pre-pubertal patients aged 5 to 11 years (inclusive) with a documented history and confirmed diagnosis of asthma of greater than or equal to 3 months.
2.Normal growth development (height between 3- and 97-percentiles according to standard growth charts).
3.Current use of either short-acting beta-2-agonist (SABA) and/or low-dose (less than or equal to 200 µg bd) inhaled corticosteroid.
4.Ability to correctly use a peak flow meter.
5.Demonstrated satisfactory technique in the use of pMDIs and spacer.
6.Willingness and ability to accurately complete patient diary cards with the assistance of their parents/ guardian.
7.Capability of reading and understanding informed consent (assent for those under the legal contractual age of consent) and the patient information leaflet by parents/ guardian.
8.Written informed consent by both parents/ guardian with assent from each patient before any trial procedure is carried out.

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 entered puberty.
2.Current or prior, i.e. in the 4 weeks preceding Visit 1, use of high-dose (> 200 µg bd) inhaled corticosteroids (for routine control of their asthma).
3.Concomitant severe diseases (e.g. bacterial infection, mycoses) or diseases which the Investigator believes are contraindications for the use of bronchodilators or which may affect the study outcome measures, including malignancy.
4.Suffering from chronic underlying systemic or lung disease, i.e., cystic fibrosis.
5.In-patient hospitalisation for acute therapy of asthma in the 3 months preceding Visit 1.
6.Current or recent (within 3 months of Visit 1) systemic (oral, parenteral or depot) corticosteroid therapy or receipt of more than three short courses of systemic corticosteroid therapy in the preceding year.
7.Continuous use of long-acting beta-agonists (inhaled, oral or otherwise) for asthma symptoms.
8.Asthma exacerbations or respiratory tract infection requiring antibiotic treatment during the past 6 weeks.
9.Known or suspected hypersensitivity to any ICS or any one of the excipients of the pressurised metered dose inhalers (pMDIs).
10.Inability to perform lung functions tests (PEF).
11.Patients who are unlikely to be compliant, take their medication as directed, complete the lung testing procedures, or attend scheduled clinic visits.
12.Participation in an investigational drug trial during 30 days preceding Visit 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified