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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-000907-41-HU
• Date of registration: 18/04/2006
• Prospective Registration: Yes
• Primary sponsor: Chiesi Farmaceutici S.p.A.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 13/06/2006
• Target sample size: 42
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000907-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: IMP used without spacer

Countries of recruitment

Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
- 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

Exclusion criteria:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Persistent moderate to severe childhood asthma (5 to 12 years of age, inclusive)
MedDRA version: 8.1 Level: PT Classification code 10049585

Intervention(s)

Trade Name: Atimos 12 microgram pressurised inhalation solution
Product Name: Atimos
Product Code: CHF 1531 HFA
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Formoterol fumarate
Current Sponsor code: CHF 1531
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 12-
Pharmaceutical form of the placebo: Pressurised inhalation, solution
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

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

Primary end point(s): Percent FEV1 change from baseline (% change in FEV1) at 3 hours post study drug

Secondary Objective:

Secondary ID(s)

DM/PR/3301/003/05