Moderate to severe asthma in adolescent patients MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
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
Sponsors
Chiesi Farmaceutici S.p.A
Eligibility
Sex/Gender
All
Inclusion 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 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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].;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). | — |
Countries
Czech Republic, Hungary
Outcome results
None listed