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A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment. (TRIPLE10)

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ClinicalTrials.gov Identifier: NCT02040597
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : October 29, 2021
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Brief Summary:
The study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after single administration of CHF 5993 pressurised Metered Dose Inhaler (pMDI) in subjects with different level of renal impairment in comparison with matching healthy volunteers. Moreover, the safety and tolerability of the study drug will be also evaluated.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Beclometasone/Formoterol/Glycopyrrolate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Non-randomized, Parallel-group Study to Investigate the Pharmacokinetics, Safety and Tolerability of a Single Dose of CHF 5993 pMDI in Subjects With Mild, Moderate and Severe Renal Impairment in Comparison With Matched Healthy Control Subjects.
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: CHF5993 pMDI
CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations
Drug: Beclometasone/Formoterol/Glycopyrrolate
Other Name: CHF 5993 pMDI

Primary Outcome Measures :
  1. Glycopyrrolate area under the curve (AUC) [ Time Frame: over 72 h after single administration ]
    AUC until the last quantifiable concentration (AUCt)

Secondary Outcome Measures :
  1. Glycopyrrolate other Pharmacokinetic parameters in plasma [ Time Frame: Over 72 h after single administration ]
    AUC until 72 h post dose (AUC0-72h), AUC extrapolated to infinity (AUCinf), maximum plasma concentratio (Cmax), time to maximum plasma concentration (tmax), half-life, clearance

  2. B17MP and Formoterol pharmacokinetic parameters in plasma [ Time Frame: over 24 h after single administration ]
    AUCt, AUC until 24 h post dose (AUC0-24h), AUCinf, Cmax, tmax, half-life, clearance

  3. BDP pharmacokinetic parameters in plasma [ Time Frame: over 24 h after single administration ]
    AUCt, AUCinf, Cmax, tmax, half-life

  4. Urine Glycopyrrolate excretion (Ae) [ Time Frame: over 72 h after single administration ]
  5. Urine formoterol excretion (Ae) [ Time Frame: Over 24 h after single administration ]
  6. Adverse events [ Time Frame: A period of 3 to 7 weeks (from screening visit to follow-up phone call) ]
    This includes a period of 3 to 7 weeks (depending on duration of screening and follow-up periods), before and after the study drug administration

  7. Vital signs [ Time Frame: over 24 h after single administration ]
    systolic and diastolic blood pressure

  8. Electrocardiogram (ECG) parameters [ Time Frame: over 24 h after single administration ]
    Heart rate (HR), time interval between ECG waves Q and T corrected for heart rate with Fridericia's formula (QTcF), time interval between the onset of the ECG wave P and the start of the QRS complex (PR), time interval between the beginning of Q wave and the termination of the S wave (QRS)

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers and
  • Subjects with mild, moderate and severe renal impairment

Exclusion Criteria:

  • pregnant or lactating women
  • positive HIV and hepatitis serology
  • history of drug abuse
  • history of hypersensitivity to the products used in the trial
  • smokers
  • respiratory disease such as asthma and COPD
  • clinically relevant concomitant disease that may introduce a risk for the subjects'safety
  • presence of kidney stones
  • dialysis

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): NCT02040597

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Biovirtus Research Site
Nadarzyn, Mokra 7, Poland, 05-830
Medical University in Lodz
Lodz, Ul. Kopcińskiego 22, Poland, 90-153
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
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Principal Investigator: Piotr Kuna, MD Medical University in Lodz
Principal Investigator: Kasia Jarus-Dziedzic, MD Biovirtus
Additional Information:
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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT02040597    
Other Study ID Numbers: CCD-05993AA1-10
2013-002140-91 ( EudraCT Number )
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021
Additional relevant MeSH terms:
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Hormones, Hormone Substitutes, and Hormone Antagonists
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
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
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Anti-Inflammatory Agents