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Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old (PAED1)

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ClinicalTrials.gov Identifier: NCT01848769
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Asthma Drug: CHF1535 pMDI + AC Plus Drug: BDP + AC Plus Drug: Formoterol + AC Plus Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010


Arm Intervention/treatment
Experimental: CHF1535 pMDI + AC Plus
Fixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device
Drug: CHF1535 pMDI + AC Plus
Four inhalations for a total dose of BDP/FF 200/24 mcg
Other Name: Fixed combination of BDP and FF 50/6 mcg

Active Comparator: BDP and Formoterol + AC Plus
Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device
Drug: BDP + AC Plus
Four inhalations for a total dose of BDP 200 mcg
Other Name: Beclomethasone Dipropionate 50 mcg with Aerochamber Plus

Drug: Formoterol + AC Plus
Four inhalations for a total dose of Formoterol 24 mcg
Other Name: Formoterol 6 mcg with Aerochamebr Plus




Primary Outcome Measures :
  1. B17MP AUC0-t [ Time Frame: pre-dose until 8hours post dose ]
    B17MP (active metabolite of BDP) systemic exposure as AUC0-t


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

    6. 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

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 ClinicalTrials.gov identifier (NCT number): NCT01848769


Locations
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Denmark
BorneAstmaKlinikken
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Hans Bisgaard, MD DMSci BorneAstmaKlinikken

Additional Information:
Publications of Results:
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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01848769     History of Changes
Other Study ID Numbers: CCD-0902-PR-0013
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by Chiesi Farmaceutici S.p.A.:
Asthma
ICS+LABA
Children
Inhalation
pMDI

Additional relevant MeSH terms:
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Formoterol Fumarate
Beclomethasone
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists