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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01191424
Recruitment Status : Completed
First Posted : August 30, 2010
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: CHF1535 NEXT DPI Drug: BDP DPI and formoterol DPI Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : October 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: CHF1535 NEXT DPI
Male and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI
Drug: CHF1535 NEXT DPI

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

Primary Outcome Measures :
  1. 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 ]
    Plasma AUC0-t for B17MP

Secondary Outcome Measures :
  1. Different pharmacokinetic parameters [ Time Frame: 0-8hrs ]
    BDP/B17MP and FF PK parameters

  2. Lung function parameters [ Time Frame: 0-8hrs ]
    Peak FEV1, FEV1 time averaged value (FEV1 AUC0-t/8).

  3. Plasma potassium [ Time Frame: 0-8hrs ]
    Plasma Potassium Cmin, tmin and AUC0-t

  4. Plasma glucose [ Time Frame: 0-8hrs ]
    Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t

  5. Heart rate [ Time Frame: 0-8hrs ]
    time averaged value (AUC0-t/8)

  6. Adverse Events [ Time Frame: during the whole study period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01191424

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chiesi Farmaceutici S.p.A. Identifier: NCT01191424     History of Changes
Other Study ID Numbers: CCD-1017-PR-0034
2010-018947-33 ( EudraCT Number )
First Posted: August 30, 2010    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by Chiesi Farmaceutici S.p.A.:

Additional relevant MeSH terms:
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
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
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists