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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Beclomethasone
Formoterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014