A 12-week, multinational, randomised, double blind, double dummy, 4-arm parallel-group study comparing the efficacy and safety of CHF 1535 (fixed combination of beclomethasone dipropionate + formoterol fumarate) 100 + 6 µg/actuation inhalation powder, administered via the NEXT™ inhaler, versus CHF 1535 (fixed combination of beclomethasone dipropionate + formoterol fumarate) 100 + 6 µg/actuation, via HFA pressurised inhalation solution, in moderate to severe symptomatic asthmatic patients aged = 12 years under treatment with inhaled corticosteroids

• Conditions: Moderate to severe symptomatic asthmatic patients aged = 18 years under treatment with inhaled corticosteroids (< 2000 µg BDP or equivalent).At least 12% of randomised patients, enrolled from pre-selectedsites, will be adolescent (i.e. 12-17 years of age).; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2008-000401-11-HU
• Lead Sponsor: CHIESI Farmaceutici S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-20
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 831

Inclusion Criteria

1. Written informed consent obtained from the patient
2. Outpatients of both sexes, aged = 18 years
3. Clinical diagnosis of moderate to severe symptomatic asthma treated with a stable daily dose of inhaled corticosteroids < 2000 µg BDP or equivalent for at least 4 weeks prior to inclusion.
4. Forced expiratory volume in the first second (FEV1) > 40% and < 80% of the predicted normal values following adequate wash-out from bronchodilators.
5. A documented positive response to the reversibility test at the screening visit, defined as ?FEV1 = 12% and = 200 mL over baseline, 30 minutes after 400 µg salbutamol pMDI (ATS/ERS taskforce 2005).
6. Evidence for partly controlled” asthma in the 2 weeks before inclusion 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. one or more of the following, other than FEV1 < 80% of the predicted normal value:
•daytime symptoms more than twice / week;
•any limitations of activities or nocturnal symptoms / awakening;
•need for reliever/rescue treatment more than twice / week.
7. Patients free of long-acting ß2-agonists (LABAs) treatment at least for 2 weeks before the screening visit;
8. Daily dose of previous inhaled corticosteroids (ICS) treatment:
•< 2000 µg of CFC BDP or non-extrafine” BDP
•< 800 µg of BDP extrafine” HFA
•< 1600 µg of budesonide
•< 1000 µg of fluticasone
•< 2000 µg of flunisolide
•<1200 µg of mometasone
•< 1280 µg of ciclesonide
9. A minimum inspiratory flow = 40 L/min evaluated with the In-Check Oral (at Visit 1).
10. Non-smokers or ex smokers with a cumulative tobacco exposure less than 5 pack years and who have stopped smoking since more than 1 year.
11. A cooperative attitude and ability to be trained in the proper use of a pMDI and a NEXT™DPI.
12. At visit 2 the partly controlled” asthma will be checked with the Asthma Control Questionnaire to check symptoms in the last 7 days (ACQ score = 1.5).
Evidence for partly controlled” asthma in the 2 weeks 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. one or more of the following, other than FEV1 < 80% of the predicted normal value:
•daytime symptoms more than twice / week;
•any limitations of activities or nocturnal symptoms/awakening
•need for reliever/rescue treatment more than twice / week.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urinary ß-HCG laboratory test (> 5 IU/ml)
2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal:
•12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml
•or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy
•or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). For females aged 12 to 17 years acceptable methods of contraception may include total abstinence at the discretion of the investigator. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
3. Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer;
4. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit);
5. Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit;
6. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (updated 2006);
7. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency;
8. Diagnosis of restrictive lung disease
9. Patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids);
10. Intolerance or contra-indication to treatment with ß2-agonists and/or inhaled corticosteroids;
11. Allergy to any component of the study treatments;
12. Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit;
13. Having received an investigational drug within 2 months before the screening visit;
14. Inability to comply with study procedures or treatment;
15. Significant medical history of 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;
16. Any patient with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable.
17. Patients with abnormal QTc at screening visit (> 450 msec-Bazett formula).

Study & Design

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