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Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old

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: NCT02787967
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Brief Summary:
The study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI) fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4 μg is compared with the free combination of licensed BDP DPI and FF DPI

Condition or disease Intervention/treatment Phase
Asthma Drug: CHF 1535 35/4µg NEXThaler® Drug: free comb. beclomethasone DPI and formoterol DPI Phase 2

Detailed Description:
This is a pharmacokinetic comparison of NEXThaler 35/4 μg versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-dose, Open-label, Randomized, 2-way Cross-over Study of CHF 1535 35/4 NEXThaler® (Fixed Combination of Beclometasone Dipropionate (BDP) 35 μg Plus Formoterol Fumarate (FF) 4 μg Versus the Free Combination of Licensed BDP DPI (Dry Powder Inhaler) and FF DPI in Asthmatic Children
Study Start Date : August 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: NEXThaler® 35/4µg
CHF 1535 35/4µg NEXThaler® Dry Powder Inhaler, 4 inhalations. Total Dose: BDP 200µg FF 16µg
Drug: CHF 1535 35/4µg NEXThaler®
4 (four) inhalations (total dose: BDP/FF 140/16 µg)

Active Comparator: Reference treatment
Drug: free comb. beclomethasone DPI and formoterol DPI 2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg
Drug: free comb. beclomethasone DPI and formoterol DPI
2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg




Primary Outcome Measures :
  1. Plasma Area Under Curve (AUC0-t) for B17MP, active metabolite of BDP [ Time Frame: predose, 15,30min, 1,2,4,6,8 hours post dose ]
    B17MP: Profile of Pharmacokinetics


Secondary Outcome Measures :
  1. B17MP Cmax [ Time Frame: predose, 15min,30min,1,2,4,6,8 hours post dose ]
    17MP: profile of pharmacokinetics

  2. BDP Area Under Curve (AUC) [ Time Frame: predose, 15min,30min,1,2,4,6,8 hours post dose ]
    BDP: profile of Pharmacokinetics

  3. Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2 [ [ Time Frame: predose, 15min, 30 min, 1,2,4,6,8 hours postdose ]
    Formoterol: profile of pharmacokinetics

  4. Formoterol Cmax [ Time Frame: predose, 15min, 30 min, 1,2,4,6,8 hours postdose ]
    Formoterol: profile of pharmacokinetics

  5. Formoterol Tmax [ Time Frame: predose, 15min, 30 min, 1,2,4,6,8 hours postdose ]
    Formoterol: profile of pharmacokinetics

  6. Formoterol T1/2 [ Time Frame: predose, 15min, 30 min, 1,2,4,6,8 hours postdose ]
    Formoterol: profile of pharmacokinetics

  7. plasma potassium Area Under Curve (AUC) [ Time Frame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose ]
    plasma potassium to evaluate drug systemic effect

  8. plasma potassium Cmin [ Time Frame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose ]
    plasma potassium to evaluate drug systemic effect

  9. plasma potassium Tmin [ Time Frame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose ]
    plasma potassium to evaluate drug systemic effect

  10. Urinary Cortisol: Amount excreted in 0-8hours (Ae),8h cortisol urinary excretion normalized for 8h creatinine excretion (Ae/Aecreat). [ Time Frame: from predose up to 8 hours postdose ]
    Urinary cortisol to evaluate drug systemic effect

  11. B17MP Tmax [ Time Frame: predose, 15min,30min,1,2,4,6,8 hours post dose ]
    BDP: profile of pharmacokinetics

  12. B17MP T1/2 [ Time Frame: predose, 15min,30min,1,2,4,6,8 hours post dose ]
    BDP: profile of pharmacokinetics

  13. BDP Cmax [ Time Frame: predose, 15min,30min,1,2,4,6,8 hours post dose ]
    BDP: profile of pharmacokinetics

  14. BDP Tmax [ Time Frame: predose, 15min,30min,1,2,4,6,8 hours post dose ]
    BDP: profile of pharmacokinetics

  15. BDP T1/2 [ Time Frame: predose, 15min,30min,1,2,4,6,8 hours post dose ]
    BDP: profile of pharmacokinetics



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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 with asthma stable enough, according to paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments.
  • Male/female children with asthma on regular treatment with ICS or using short-acting inhaled 2-agonist as reliever to control asthma symptoms.
  • Age ≥ 5 < 12 years (8 to 10 children in the age range 5-8 years old).
  • Children with a forced expiratory volume in one second (FEV1)>70% of predicted values (% pred) after withholding 2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment.
  • A cooperative attitude and ability to be trained about the proper use of DPI, ability to use correctly the medical devices and compliant to study procedures

Exclusion Criteria:

  • Past or present diagnosis of cardiovascular, renal or liver disease.
  • Known hypersensitivity to the active treatmen
  • Exacerbation of asthma symptoms within 4 weeks prior to screening.
  • Inability to perform the required breathing technique and blood sampling.
  • Hospitalization due to exacerbation of asthma within 1 month prior to screening (Visit 1).
  • Lower respiratory tract infection within 1 month prior to screening (Visit 1).
  • 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): NCT02787967


Locations
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Denmark
BørneAstmaKlinikken, Hans Knudsens Plads 1A,
Copenaghen, Denmark
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Hans Bisgaard, MD Copenhagen Studies on Asthma in Childhood
Additional Information:
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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT02787967    
Other Study ID Numbers: CCD-01535BB1-01
2015-005152-10 ( EudraCT Number )
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Beclomethasone
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists