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. (ADONE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01191424
First received: August 27, 2010
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: CHF1535 NEXT DPI
Drug: BDP DPI and formoterol DPI
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Multinational, Single-Dose, Open Label, Randomized, 2-Way Crossover, Clinical Pharmacology Study of CHF 1535 100/6 Next™ DPI (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg) Versus the Free Combination of Licensed Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescents and Adult Patients

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Systemic exposure to B17MP (active metabolite of BDP) after single dose (4 inhalations) of CHF1535 100/6 NEXT DPI in comparison with an already approved free combination of BDP DPI and FF DPI [ Time Frame: 0-8hrs ] [ Designated as safety issue: Yes ]
    Plasma AUC0-t for B17MP


Secondary Outcome Measures:
  • Different pharmacokinetic parameters [ Time Frame: 0-8hrs ] [ Designated as safety issue: Yes ]
    BDP/B17MP and FF PK parameters

  • Lung function parameters [ Time Frame: 0-8hrs ] [ Designated as safety issue: Yes ]
    Peak FEV1, FEV1 time averaged value (FEV1 AUC0-t/8).

  • Plasma potassium [ Time Frame: 0-8hrs ] [ Designated as safety issue: Yes ]
    Plasma Potassium Cmin, tmin and AUC0-t

  • Plasma glucose [ Time Frame: 0-8hrs ] [ Designated as safety issue: Yes ]
    Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t

  • Heart rate [ Time Frame: 0-8hrs ] [ Designated as safety issue: Yes ]
    time averaged value (AUC0-t/8)

  • Adverse Events [ Time Frame: during the whole study period ] [ Designated as safety issue: Yes ]

Enrollment: 57
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHF1535 NEXT DPI
Male and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI
Drug: CHF1535 NEXT DPI
FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER
Active Comparator: 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
Drug: BDP DPI and formoterol DPI
FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main 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;

Main 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191424

Locations
Denmark
Copenhagen University Hospital
Copenhagen, Denmark, 2800
United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Study Director: Dave Singh, MD Medicines Evaluation Unit
Study Director: Hans Bisgaard, MD Copenhagen University Hospital
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01191424     History of Changes
Other Study ID Numbers: CCD-1017-PR-0034, 2010-018947-33
Study First Received: August 27, 2010
Last Updated: November 16, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Medicines Agency

Keywords provided by Chiesi Farmaceutici S.p.A.:
Asthma
PK
Adolescents
Adults

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Formoterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014