A single dose, randomised, double blind, double dummy, placebo-controlled, three-period crossover clinical study, comparing the efficacy, safety and tolerability of Formoterol-HFA pMDI 12 microgram per actuation administered by means of a spacer device (AeroChamber Plus) with that of Formoterol-HFA pMDI 12 microgram per actuation in 5- to 12-year-old children with persistent moderate to severe asthma
- Conditions
- Persistent moderate to severe childhood asthma (5 to 12 years of age, inclusive)MedDRA version: 8.1Level: PTClassification code 10049585
- Registration Number
- EUCTR2006-000907-41-HU
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 42
- Written informed consent obtained by parent/legal guardian.
- Boys and girls aged 5 to 12 years inclusive.
- Clinical diagnosis of persistent moderate to severe asthma stable for at least 2 months, according to the Classification of Asthma Severity of the Global Initiative for Asthma, Updated 2005.
- Patient on a stable dose, same formulation, of an inhaled corticosteroid (ICS) for at least 2 months before the screening visit. The daily taken dose, and also the formulation, of this inhaled corticosteroid need to remain constant throughout the
study.
- Patient free of an inhaled long-acting beta2-agonist (LABA) for at least 2 months before the screening visit.
- Patient free of an inhaled fixed combination” long-acting beta2-agonist plus corticosteroid pMDI or DPI for at least 2 months before the screening visit.
- FEV1 greater or equal to 60% and < 80% of the predicted normal value.
- If the patient has not respected the conventional wash-out of 8 hours for short-acting beta2-agonists at the Visit 1 and:
if the FEV1 measurement is greater or equal to 80%, there is the possibility to take into account a previous FEV1 measurement for his enrolment in the run-in period.
This one has to be greater than or equal to 60% and < 80% performed during the last month. In such a case, FEV1 will be retested at Visit 2 after a conventional short-acting beta2-agonist treatment wash-out. If the FEV1 is still again greater or equal to 80% of the predicted normal value the patient will not be randomised to treatments; in such a case only, if the change in FEV1 is less than 12% at Visit 1, this criterion will need to be met before Visit 2, after a conventional 8-hour wash-out.
- A change in FEV1 from (pre-salbutamol) baseline value greater than or equal to 12%, 30 minutes following inhalation of 200 µg of salbutamol pMDI.
- A cooperative attitude and ability to be trained in the proper use of a pMDI and spacer (AeroChamber Plus).
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
- Intake of an investigational drug within 2 months prior to screening visit.
- No or poor co-ordination of actuation and inhalation.
- Inability to perform spirometry.
- Unwilling, or potentially unreliable patients or patients with a history of non compliance to medical therapy.
- History of malignancy or treatment for malignancy within 5 years of the screening visit.
- Other significant concomitant medical condition, or paraclinical evaluation indicating a significant medical condition, which might compromise patient safety, compliance, and/or interfere with test treatments evaluation.
- Seasonal asthma or asthma occurring only during episodic exposure to an allergen.
- History of cystic fibrosis or bronchiectasis.
- Vaccination with live-attenuated virus within 2 months of the screening visit.
- Change in daily dose, dosing schedule, formulation of an inhaled corticosteroid in the previous 2 months, or during the run-in period.
- Use of an inhaled long-acting beta2-agonist in the previous 2 months, or during the run-in period.
- Use of an inhaled fixed combination” long-acting beta2-agonist plus corticosteroid pMDI or DPI in the previous 2 months, or during the run-in period.
- An acute asthma exacerbation in the previous 2 months, or during the run-in period.
- Respiratory tract infection in the previous 2 months or during the run-in period.
- Parenteral or oral corticosteroids in the previous 2 months or during the run-in period.
- Use of cromolyn sodium, nedocromil, leukotriene modifiers, ketotifen, theophylline (any formulation), inhaled anticholinergics, antibiotics for a lower respiratory tract
infection, oral or nebulized beta2-agonists, nebulized corticosteroids in the previous 2 months, or during the run-in period.
- Intolerance or past reaction to test treatments or excipients/propellant gases.
- Use of astemizole or terfenadine in the previous 2 months and use of any antihistamine during the run-in period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to demonstrate that Formoterol-HFA pMDI 12 µg with spacer (AeroChamber Plus) is clinically equivalent in terms of efficacy to Formoterol-HFA pMDI following a single dose administration in 5- to 12-year-old children with persistent moderate to severe asthma;Secondary Objective: ;Primary end point(s): Percent FEV1 change from baseline (% change in FEV1) at 3 hours post study drug
- Secondary Outcome Measures
Name Time Method