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Completed

NCT Number: NCT01848769

Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old

The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

BorneAstmaKlinikken

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male/Female children aged 5-11 years
  • Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
  • children with stable asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
  • Forced expiratory volume in one second (FEV1) > 70% of predicted values (% pred) after withholding beta2-agonist treatment for a minimum of 4 h prior to each dose period.
  • A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device and compliant to study procedures.

Exclusion criteria

  • Past or present diagnoses of cardiovascular, renal or liver disease
  • Known hypersensitivity to the active treatments
  • Exacerbation of asthma symptoms within the previous 4 weeks
  • Inability to perform the required breathing technique and blood sampling
  • Hospitalization due to exacerbation of asthma within 1 month prior to inclusion
  • Lower respiratory tract infection within 1 month prior to inclusion
  • Disease (other than asthma) which might influence the outcome of the study
  • Obesity, i.e. > 97% weight percentile by local standards

Treatment and study plan

CHF1535 pMDI + AC Plus

Drug

Four inhalations for a total dose of BDP/FF 200/24 mcg

Other names: Fixed combination of BDP and FF 50/6 mcg

BDP + AC Plus

Drug

Four inhalations for a total dose of BDP 200 mcg

Other names: Beclomethasone Dipropionate 50 mcg with Aerochamber Plus

Formoterol + AC Plus

Drug

Four inhalations for a total dose of Formoterol 24 mcg

Other names: Formoterol 6 mcg with Aerochamebr Plus

Primary outcomes

  1. B17MP AUC0-t

    Time frame: pre-dose until 8hours post dose

    B17MP (active metabolite of BDP) systemic exposure as AUC0-t

Secondary outcomes

  1. B17MP PK profile

    Time frame: pre-dose until 8 hours post-dose

  2. BDP PK prolile

    Time frame: Pre-dose until 8 hours post-dose

  3. Formoterol PK profile

    Time frame: Pre-dose until 8 hours post-dose

  4. Plasma potassium AUC, Cmin, tmin

    Time frame: Pre-dose until 8 hours post-dose

    Plasma potassium to evaluate drug systemic effect

  5. Urinary Cortisol excretion

    Time frame: Pre-dose until 8 hours post-dose

    8h urinary excretion of cortisol and 8h urinary excretion of cortisol normalized for 8h creatinine excretion to evaluate dru systemic effects

  6. Glucose in urine

    Time frame: Pre-dose until 8 hours post-dose

    Glucose to evaluate the drug systemic effects

  7. Heart rate Time averaged heart rate value (AUC0-t)/t

    Time frame: Pre-dose until 8 hours post-dose

    Heart rate to evaluate the drug systemic effects

  8. Spirometry: PEF

    Time frame: Pre-dose until 8 hours post-dose

    Peak respiratory flow as a measure of drug efficacy

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

A Single-dose, Open-Label, 2-Way Cross-Over, Clinical Pharmacology Study Of Chf 1535 50/6 HFA pMDI (Fixed Combination Of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6 µg) Using The Aerochamber Plus™ Spacer Device Versus The Free Combination Of Beclomethasone HFA pMDI And Formoterol HFA pMDI Available On The Market Using The Aerochamber Plus™ Spacer Device In Asthmatic Children

Acronym: PAED1

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 7, 2013
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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