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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)

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.
 
ClinicalTrials.gov Identifier: NCT01848769
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Tracking Information
First Submitted Date  ICMJE May 3, 2013
First Posted Date  ICMJE May 7, 2013
Last Update Posted Date July 31, 2020
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
B17MP AUC0-t [ Time Frame: pre-dose until 8hours post dose ]
B17MP (active metabolite of BDP) systemic exposure as AUC0-t
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
  • B17MP PK profile [ Time Frame: pre-dose until 8 hours post-dose ]
  • BDP PK prolile [ Time Frame: Pre-dose until 8 hours post-dose ]
  • Formoterol PK profile [ Time Frame: Pre-dose until 8 hours post-dose ]
  • Plasma potassium AUC, Cmin, tmin [ Time Frame: Pre-dose until 8 hours post-dose ]
    Plasma potassium to evaluate drug systemic effect
  • 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
  • Glucose in urine [ Time Frame: Pre-dose until 8 hours post-dose ]
    Glucose to evaluate the drug systemic effects
  • 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
  • Spirometry: PEF [ Time Frame: Pre-dose until 8 hours post-dose ]
    Peak respiratory flow as a measure of drug efficacy
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
  • B17MP Cmax, Tmax, T1/2 [ Time Frame: pre-dose until 8 hours post-dose ]
    B17MP PK profile
  • BDP AUC, Tmax Cmax, T1/2 [ Time Frame: Pre-dose until 8 hours post-dose ]
    BDP PK profile
  • Formoterol AUC, Cmax, Tmax, T1/2 [ Time Frame: Pre-dose until 8 hours post-dose ]
    Formoterol PK profile
  • Plasma potassium AUC, Cmin, tmin [ Time Frame: Pre-dose until 8 hours post-dose ]
    Plasma potassium to evaluate drug systemic effect
  • Urinary Cortisol Ae and Ae/Aecreat [ 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
  • Glucose in urine [ Time Frame: Pre-dose until 8 hours post-dose ]
    Glucose to evaluate the drug systemic effects
  • 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
  • Spirometry: PEF [ Time Frame: Pre-dose until 8 hours post-dose ]
    Peak respiratory flow as a measure of drug efficacy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: CHF1535 pMDI + AC Plus
    Fixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device
    Intervention: Drug: CHF1535 pMDI + AC Plus
  • Active Comparator: BDP and Formoterol + AC Plus
    Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device
    Interventions:
    • Drug: BDP + AC Plus
    • Drug: Formoterol + AC Plus
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2013)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848769
Other Study ID Numbers  ICMJE CCD-0902-PR-0013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chiesi Farmaceutici S.p.A.
Study Sponsor  ICMJE Chiesi Farmaceutici S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hans Bisgaard, MD DMSci BorneAstmaKlinikken
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP