A 12-WEEK, MULTICENTER, MULTINATIONAL, RANDOMISED, DOUBLE BLIND, DOUBLE-DUMMY (OPEN LABEL FOR THE SPACER GROUP), 3-ARM PARALLEL GROUP STUDY COMPARING THE EFFICACY AND THE SAFETY OF CHF 1535 HFA pMDI (BDP/FF 100/6 µg per actuation) 2 PUFFS BID VERSUS BDP HFA pMDI (250 µg per actuation) 2 PUFFS BID, IN ADOLESCENT PATIENTS WITH MODERATE TO SEVERE PERSISTENT ASTHMA

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-000522-46-CZ
• Date of registration: 25/05/2007
• Prospective Registration: Yes
• Primary sponsor: Chiesi Farmaceutici S.p.A
• Public title: A 12-WEEK, MULTICENTER, MULTINATIONAL, RANDOMISED, DOUBLE BLIND, DOUBLE-DUMMY (OPEN LABEL FOR THE SPACER GROUP), 3-ARM PARALLEL GROUP STUDY COMPARING THE EFFICACY AND THE SAFETY OF CHF 1535 HFA pMDI (BDP/FF 100/6 µg per actuation) 2 PUFFS BID VERSUS BDP HFA pMDI (250 µg per actuation) 2 PUFFS BID, IN ADOLESCENT PATIENTS WITH MODERATE TO SEVERE PERSISTENT ASTHMA
• Scientific title: A 12-WEEK, MULTICENTER, MULTINATIONAL, RANDOMISED, DOUBLE BLIND, DOUBLE-DUMMY (OPEN LABEL FOR THE SPACER GROUP), 3-ARM PARALLEL GROUP STUDY COMPARING THE EFFICACY AND THE SAFETY OF CHF 1535 HFA pMDI (BDP/FF 100/6 µg per actuation) 2 PUFFS BID VERSUS BDP HFA pMDI (250 µg per actuation) 2 PUFFS BID, IN ADOLESCENT PATIENTS WITH MODERATE TO SEVERE PERSISTENT ASTHMA
• Date of first enrolment: 11/07/2007
• Target sample size: 426
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000522-46
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Double Dummy, Open Label for spacer group If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: Clenil® 250

Countries of recruitment

Czech Republic, Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
Patients will be enrolled at Visit 1 into the 2-week run-in period if they meet all the following criteria:
1. Male or female patient, aged =12 and < 18 years.
2. Subject’s and parents/legal representatives written informed consent.
3. Clinical diagnosis of persistent moderate/severe asthma, already treated with inhaled corticosteroids at a stable dose for at least 4 weeks prior to inclusion.
4. Evidence for “partly controlled” asthma during the 2-week run-in period, according to the Classification of Asthma Severity and Levels of Asthma Control of the Global Strategy for Asthma Management and Prevention (GINA, revised 2006), i.e. any of the followings, other than lung function (FEV1) < 80% predicted already checked at visit 1:
- daytime symptoms more than twice/week
- any limitations of activities or nocturnal symptoms/awakening
- need for reliever/rescue treatment more than twice a week.
5. Daily dose of previous inhaled corticosteroids treatment: = 500 - = 750 µg of BDP-CFC, = 200 - = 400 µg of BDP extrafine - HFA, = 250 - = 400 µg of fluticasone, = 400 - = 600 µg of budesonide, = 400 - = 600 µg of mometasone.
6. FEV1 = 40% and < 80% of the predicted normal values (and at least 0.7 L absolute value) following adequate wash-out from bronchodilators.
7. A documented positive response to the reversibility test, defined as ?FEV1 > 12% and > 200 mL over baseline, 30 minutes after 400 µg salbutamol pMDI.
8. A cooperative attitude and ability to be trained in the proper use of a pMDI.

Inclusion criteria 4 is to be reviewed and met at visit 2 for the patient to be eligible for randomisation in the study.

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:
Patients will not be enrolled at visit 1 into the run-in period if they meet one or more of the following criteria:
1. Pregnant or lactating girl. Sexually active female not using efficient contraception (e.g. oestro-progestatives, condoms).
2. Having received an investigational drug within 2 months before the screening visit.
3. Inability to comply to study procedures or to study treatment intake.
4. Occurrence of acute asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit.
5. Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
6. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
7. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit).
8. Diagnosis of restrictive lung disease (e.g. kyphoscoliosis, ankylosing spondylitis, FEV1/FVC >70%).
9. Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient’s safety, compliance, or study evaluations, according to the investigator’s opinion.
10. Cancer or any other chronic disease with poor prognosis and /or affecting patient status.
11. Smoking patient (current and past smoker).
12. QTc interval (Bazett’s formula) higher than 450 msec at screening visit (visit 1).
13. Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids.
14. Allergy to any component of the study treatments.
15. Patient treated with inhaled LABAs in the 4 weeks prior to screening visit.
16. Any change in dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit.
17. Patient treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids).



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

Health Condition(s) or Problem(s) studied

Moderate to severe asthma in adolescent patients
MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma

Intervention(s)

Trade Name: Foster®100/6
Product Name: CHF 1535
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: beclomethasone dipropionate
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: formoterol fumarate dihydrate
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Inhalation vapour, solution
Route of administration of the placebo: Inhalation use

Trade Name: Clenil® 250
Product Name: Beclomethasone dipropionate 250µg HFA pMDI
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: beclometasone-17,21-dipropionate
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Inhalation vapour, solution
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Secondary Objective: Secondary objectives will be to evaluate the effects of the therapy (both with and without spacer) on other lung function parameters, on clinical outcome measures, and to assess the safety and the tolerability of both CHF 1535 regimens in adolescents.

Main Objective: The primary objective of the study is to demonstrate the clinical superiority in terms of pulmonary function (change from baseline in pre-dose morning PEF) of CHF 1535 versus a corresponding, in terms of equipotency, dose of beclomethasone monotherapy in adolescent patients with partly controlled moderate to severe persistent asthma over a 12-week treatment period. The two study treatments will be administered via a pMDI standard actuator (without a spacing device).

Primary end point(s): Change from baseline in pre-dose morning PEF (L/min) [the mean of the last 7 available values during the run-in period and during the last 14 days of the treatment period will be considered].

Secondary ID(s)

CCD-0606-PR-0019