A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.

NCT ID: NCT01191424

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-09-30

Brief Summary

The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a free combination of BDP DPI plus FF DPI licensed products after a morning dose administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic patients.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CHF1535 NEXT DPI

Male and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI

Group Type: EXPERIMENTAL

CHF1535 NEXT DPI

Intervention Type: DRUG

FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER

Free combination BDP and FF

Male and female adolescents and adult patients (≥ 12 years old) treated with a free combination of licenced BDP and FF

Group Type: ACTIVE_COMPARATOR

BDP DPI and formoterol DPI

Intervention Type: DRUG

FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI

Interventions

CHF1535 NEXT DPI

FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER

Intervention Type: DRUG

BDP DPI and formoterol DPI

FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male and female adolescents (≥ 12 years old) and adults (≥18 and ≤ 65 years old)

2. Written informed consent;

3. Diagnosis of asthma as defined in the GINA guidelines;

4. Patients with stable asthma, according to the Investigator's opinion;

5. Asthmatic patients already treated with ICS or using short-acting inhaled β2-agonists as reliever to control asthma symptoms;

6. Patients with a forced expiratory volume in one second (FEV1) > 70% of predicted values;

7. Patients with a peak inspiratory flow (PIF) > 40 L/min

8. Reversibility test;

9. Non- or ex-smokers;

10. A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures;

Exclusion Criteria

1. Pregnant or lactating female;

2. Having received an investigational drug within 2 months before the screening visit

3. Diagnosis of COPD as defined by the current GOLD guidelines;

4. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality;

5. Known hypersensitivity to the active treatments;

6. History of drug addiction or excessive use of alcohol;

7. Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening;

8. Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit;

9. Inability to perform the required breathing technique and blood sampling;

10. Lower respiratory tract infection within 1 month prior to the screening visit;

11. Blood donation (450 mL or more) or significant blood loss in the 12 weeks before the screening visit.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dave Singh, MD

Role: STUDY_DIRECTOR

Medicines Evaluation Unit

Hans Bisgaard, MD

Role: STUDY_DIRECTOR

Copenhagen University Hospital at Herlev

Locations

Copenhagen University Hospital

Copenhagen, , Denmark

Medicines Evaluation Unit

Manchester, , United Kingdom

Countries

Denmark; United Kingdom

References

Govoni M, Piccinno A, Lucci G, Poli G, Acerbi D, Baronio R, Singh D, Kuna P, Chawes BL, Bisgaard H. The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size. Pulm Pharmacol Ther. 2015 Feb;30:102-9. doi: 10.1016/j.pupt.2014.04.003. Epub 2014 Apr 16.

Reference Type: BACKGROUND

PMID: 24746942 (View on PubMed)

Chawes BL, Govoni M, Piccinno A, Kreiner-Moller E, Vissing NH, Mortensen L, Nilsson E, Bisgaard A, Deleuran M, Skytt N, Samandari N, Acerbi D, Bisgaard H. A clinical pharmacology study of fixed vs. free combination of inhaled beclometasone dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescents. Br J Clin Pharmacol. 2014 Nov;78(5):1169-71. doi: 10.1111/bcp.12424. No abstract available.

Reference Type: RESULT

PMID: 24830339 (View on PubMed)

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2010-018947-33

Study Record on EU Clinical Trials Register including results

Other Identifiers

2010-018947-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCD-1017-PR-0034

Identifier Type: -

Identifier Source: org_study_id