A phase III, 8-week, multinational, multicentre, randomized, double-blind, triple-dummy, active controlled, 3-arm parallel-group clinical trial to test the efficacy of CHF 1535 (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg) via NEXT DPI® 1 inhalation bid versus same dose of CHF 1535 pMDI and marketed beclomethasone DPI 100 µg 1 inhalation bid on Peak Expiratory Flow in adult asthmatic patients after one month of treatment with marketed fixed dose combination of FOSTER® 1 inhalation bid.

Phase 1

• Conditions: ASTHMA; MedDRA version: 12.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2010-023281-47-BG
• Lead Sponsor: Chiesi Farmaceutici SpA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-24
• Study Completion: 2011-08-29
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 888

Inclusion Criteria

1. Male and female adults (=18 years old).
2. Written informed consent obtained by the patient prior to any study-related procedures.
3. Diagnosis of asthma as defined in the GINA guidelines, update 2009 at least in the 6 months before the screening visit.
4. A documented positive response to the reversibility test (within the last 6 months) defined as ?FEV1 = 12% and = 200 mL over baseline, 30 minutes after 400 µg salbutamol pMDI (ATS/ERS taskforce 2005). In case the patient doesn’t have any documented reversibility test, this test will be performed at the screening.
5. Patients with a forced expiratory volume in one second (FEV1) > 80% of the predicted values following adequate wash-out from bronchodilators.
6. Asthma Control Questionnaire (ACQ) score < 1.25. This will be confirmed at V3.
7. Asthmatic patients already treated with medium daily dose of ICS (e.g. BDP or equivalent = 1000 µg/die) or low dose of ICS/LABA fixed combination (e.g. salmeterol/fluticasone 100/500 µg/die).
8. Non- or ex-smokers who smoked less than 5 pack-years and stopped smoking for at least 1 year. (Pack/year: number of cigarette smoked per day multiplied by the number of years of smoking/20).
9. Ability to a proper use of pMDI and DPI devices and electronic peak flow meter.
10. A cooperative attitude to be compliant with study procedures.
11. Presence of at least 7 available pre-dose morning PEF measurements in the last 14 days of the run-in period.

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 already documented serum FSH levels > 40 mIU/mL or are using one or more of the following acceptable methods of contraception.
a.surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)
b.hormonal contraception (implantable, patch, oral)
c.double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)
A urinary pregnancy test will be performed at screening and at the last visit 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, hospitalization for asthma exacerbation in Intensive Care Unit).
4. Diagnosis of COPD as defined by the current GOLD guidelines, updates 2009.
5. Hospitalization due to asthma exacerbation within 1 month prior to the screening visit or moderate/severe asthma exacerbation during the run-in period.
6. Lower respiratory tract infection within 1 month prior to the screening visit.
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 before the screening visit (3 months for parenteral depot corticosteroids).
10. Intolerance or contra-indication to treatment with ?2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments.
11. Having received an investigational drug within 1 month before the screening visit.
12. 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.
13. 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.

Study & Design

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