A phase II, multinational, multicentre, double blind, double dummy, randomised, 5-way cross-over, placebo and active controlled clinical study to test the non-inferiority of a single dose of CHF 1535 (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg dry powder) via NEXT™ DPI 1 or 4 inhalations versus CHF 1535 (beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg) pMDI with HFA-134a propellant 1 or 4 puffs on FEV1 AUC0-12h in partly controlled adult asthmatic patients

Conditions: Partly controlled asthma in adult patients
MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

Registration Number: EUCTR2008-004842-10-GB

Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 65

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for enrolment into the study:
1. Patient’s written informed consent obtained prior to any study-related procedures. Patients incapable of giving consent personally or vulnerable patients (except women of childbearing potential with acceptable method of contraception) cannot be included in the study.
2. Outpatient male or female aged = 18 years.
3. Evidence for partly controlled” asthma in the 2 weeks before the screening visit (during the pre-screening period) according to the Classification of Asthma Severity and Levels of Asthma Control of the Global Strategy for Asthma Management and Prevention (GINA guidelines 2006) i.e. one or more of the following: - daytime symptoms more than twice / week; - any limitations of activities or nocturnal symptoms / awakening; - need for reliever/rescue treatment more than twice / week.
4. Daily dose of previous inhaled corticosteroids (ICS) treatment at the screening visit:
a. = 2000 µg of CFC BDP or BDP non-extrafine”
b. = 800 µg of BDP extrafine” HFA
c. = 1600 µg of budesonide
d. = 1000 µg of fluticasone
e. = 2000 µg of flunisolide
f. = 1200 µg of mometasone
g. = 1280 µg of ciclesonide
5. Forced expiratory volume in the first second (FEV1) = 60% and = 90% of the predicted normal values at the screening visit.
6. 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).
7. Patients free of long-acting beta ?2-agonists (LABAs) treatment for at least 2 weeks before the screening visit.
8. Patients free of short-acting ?beta 2-agonists (SABAs) treatment for at least 6 hours before the screening visit.
9. Non-smokers or ex-smokers with a cumulative tobacco exposure less than 5 pack-years and who have stopped smoking for more than 1 year (pack-year: number of cigarettes smoked per day multiplied by the number of years of smoking divided by 20).
10. A cooperative attitude and ability to be trained in the proper use of a pMDI and a DPI.

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 lactating women or all women physiologically capable of becoming pregnant 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 are using one or more of the following highly effective and acceptable methods of contraception.
a. surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)
b. hormonal contraception (implantable, injectable, patch, oral)
c. double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)

A urine pregnancy test will be performed at screening in women of childbearing potential.
2. Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
3. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit) within 1 year before screening.
4. Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit.
5. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (updated 2006).
6. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
7. Diagnosis of restrictive lung disease.
8. Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
9. Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids.
10. Allergy, sensitivity or intolerance to study drugs or excipients.
11. Patients who received any investigational new drug, or participated in clinical study within the last 8 weeks before the screening. The patients cannot participate in another clinical study as the same time as the present study.
12. Subjects unlikely to comply with the study protocol or unable to understand the nature and scope of the study but also the possible benefits or unwanted effects of the study treatments.
13. 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.