Multinational Clinical Trial of 12 weeks of duration to test the efficacy of a new drug called CHF 1535 50/6 (fixed combination of a corticoteroid and a long-acting Beta 2 agonist) compared to a free combination of the same substances, and to the corticosteroid only in asthmatic childre

Phase 1

• Conditions: Asthma; MedDRA version: 14.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2009-016757-18-ES
• Lead Sponsor: Chesi Farmaceutici SpA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-02
• Study Completion: 2012-09-28
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 638

Inclusion Criteria

1. Written informed consent obtained from the parents/legal representatives (according to the local regulation) and written or verbal assent by the patient (when appropriate) prior to any study related procedures.
For France: only patients registered under a social welfare can be included in the study.
2. Prepuberal male and female outpatients, aged ? 5 and < 12 years in Tanner stages I and II according to Investigator's assessment.
3. Clinical diagnosis of asthma (GINA revised 2009) at least six months prior to screening visit.
4. Evidence of ?partly controlled? asthma during the 2-week run-in period defined as following (GINA revised 2009), i.e. at least one of the following:
- daytime symptoms more than twice/week,
- any limitations of activities,
- any nocturnal symptoms / awakening,
- need for reliever/rescue treatment more than twice a week.
5. Treated with inhaled ?2-agonists as required.
6. Symptomatic asthmatic patients treated with inhaled beclomethasone dipropionate (BDP) up to 400 ?g or equivalent at a stable dose for at least 4 weeks prior to screening visit.
Equivalence to:
BDP non-extrafine ? 400 ?g
BDP extrafine ? 200 ?g
Budesonide ? 400 ?g
Ciclesonide ? 320 ?g
Flunisolide ? 1250 ?g
Fluticasone ? 500 ?g
Mometasone ? 400 ?g
Triamcinolone ?1200 ?g
Patients under combination ICS-LABA or ICS-LTRA can enter into the study at the corresponding ICS dose, according to GINA guidelines (i.e. maximum 200 ?g of non-extrafine BDP or equivalent).
7. A documented positive response to the reversibility test, defined as ?FEV1 ? 12% over baseline, 15 minutes after 400 ?g salbutamol pMDI via a Volumatic? spacer device (ATS/ERS taskforce 2005) within 6 months prior to the screening must be provided. If not available, this test must be done at screening.
8. Forced Expiratory Volume during the first second (FEV1) ? 60% and ? 95% of predicted normal values at the screening visit and at the randomisation visit.
9. A cooperative attitude/ability and physical capacity to use a pMDI and a spacer device and perform lung functions.
Are the trial subjects under 18? yes
Number of subjects for this age range: 700
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 with two or more admissions to hospital for asthma exacerbation in the past 12 months or any admission to intensive care ever.
2. Any concomitant disease requiring additional treatment with systemic glucocorticosteroids.
3. Regular use of anticholinergics.
4. Allergy to one component of medications used.
5. Intolerance or contra-indication to treatment with ?2-agonists and/or inhaled corticosteroids.
6. Having received an investigational drug within 2 months before the current study.
7. Patients and/or parents unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments.
8. Occurrence of acute asthma exacerbations or lower respiratory tract infections in the 4 weeks preceding the screening visit or during the run-in period.
9. History of cystic fibrosis, bronchiectasis, primary ciliary dyskinesia, bronchopulmonary dysplasia, or previous premature children with less than 36 weeks of gestational age.
10. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit).
11. Diagnosis of restrictive lung disease.
12. 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.
13. QTc interval (Fridericia?s formula) higher than 450 msec (for boys) and 470 msec (for girls) at screening visit and randomisation visit.
14. Current smokers.

Study & Design

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