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Completed

NCT Number: NCT01191424

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.

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.

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Key information

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Copenhagen University Hospital, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Male and female adolescents (≥ 12 years old) and adults (≥18 and ≤ 65 years old)
  • Written informed consent;
  • Diagnosis of asthma as defined in the GINA guidelines;
  • Patients with stable asthma, according to the Investigator's opinion;
  • Asthmatic patients already treated with ICS or using short-acting inhaled β2-agonists as reliever to control asthma symptoms;
  • Patients with a forced expiratory volume in one second (FEV1) > 70% of predicted values;
  • Patients with a peak inspiratory flow (PIF) > 40 L/min
  • Reversibility test;
  • Non- or ex-smokers;
  • A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures;

Main Exclusion Criteria:

  • Pregnant or lactating female;
  • Having received an investigational drug within 2 months before the screening visit
  • Diagnosis of COPD as defined by the current GOLD guidelines;
  • Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality;
  • Known hypersensitivity to the active treatments;
  • History of drug addiction or excessive use of alcohol;
  • Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening;
  • Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit;
  • Inability to perform the required breathing technique and blood sampling;
  • Lower respiratory tract infection within 1 month prior to the screening visit;
  • Blood donation (450 mL or more) or significant blood loss in the 12 weeks before the screening visit.

Treatment and study plan

CHF1535 NEXT DPI

Drug

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

BDP DPI and formoterol DPI

Drug

FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study 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

Acronym: ADONE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 30, 2010
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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