Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 36 of 186 for:    GLYCOPYRROLATE

Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients (TRIPLE 4)

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: NCT02119234
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Brief Summary:
The study is performed to investigate the effect of the spacing device on the pharmacokinetics of CHF 5993 pMDI active ingredients administered with and without Aerochamber Plus Flow-vu antistatic VHC spacer as a single administration in COPD patients. Moreover, the general safety and tolerability of the treatments will be evaluated.

Condition or disease Intervention/treatment Phase
COPD Drug: Beclometasone/formoterol/glycopyrrolate Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Randomized, 3-way Cross-over, Placebo Controlled, Single Dose Clinical Pharmacology Study in COPD Patients After Inhalation of CHF 5993 pMDI Using the Standard Actuator With or Without AeroChamber Plus Flow-Vu VHC Spacer
Study Start Date : March 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CHF5993 pMDI + Spacer
CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using Aerochamber Plus Flow-vu VHC spacer
Drug: Beclometasone/formoterol/glycopyrrolate
Other Name: CHF5993 pMDI

Active Comparator: CHF5993 pMDI
CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using standard actuator only
Drug: Beclometasone/formoterol/glycopyrrolate
Other Name: CHF5993 pMDI

Placebo Comparator: Placebo pMDI
Placebo pMDI x 4 inhalations
Drug: Placebo



Primary Outcome Measures :
  1. Area under the curve of B17MP, formoterol and glycopyrrolate [ Time Frame: Over 24 and 48h after single administration ]

    AUCt (up to the last quantifiable concentration) and Cmax (maximum concentration) from plasma concentrations vs time profiles.

    over 24h for formoterol and B17MP, over 48h for glycopyrrolate



Secondary Outcome Measures :
  1. Other pharmacokinetic parameters for formoterol, glycopyrrolate and B17MP in plasma [ Time Frame: over 24 or 48h after single administration ]
    B17MP AUC0-30min, AUC0-24h, AUCinf, tmax, half-life Formoterol AUC0-30min, AUC0-24h, AUCinf, tmax, half-life Glycopyrrolate AUC0-30min, AUC0-48h, AUCinf, tmax, half-life

  2. Adverse events [ Time Frame: over a period of 6 to 11 weeks ]
    from the signature of the informed consent until the follow-up phone call

  3. Lung function [ Time Frame: 30 min after single administration ]
    FEV1

  4. plasma cortisol [ Time Frame: over 24 h after single administration ]
    cortisol AUC0-24h, Cmin and tmin

  5. cortisol urinary excretion [ Time Frame: over 24 h after single administration ]
    cortisol excretion corrected and not corrected for creatinine

  6. potassium plasma profile [ Time Frame: over 24 h after single administration ]
    potassium AUC0-24h, tmin and Cmin

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

  8. ECG parameters [ Time Frame: over 24 h after single administration ]
    extracted from holter recording HR, QTcF, PR and QRS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD patients
  • smokers or ex-smokers
  • post-bronchodilator FEV1 between 30 and 60% of predicted value

Exclusion Criteria:

  • Positive serology to HIV and hepatitis
  • Known respiratory disorder other than COPD
  • Recent COPD exacerbations or hospitalization for COPD
  • Treatment with non-permitted concomitant medication
  • clinically relevant concomitant disease
  • clinically relevant abnormal laboratory or ECG parameters

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): NCT02119234


Locations
Layout table for location information
Poland
Medical University in Lodz
Lodz, ul. Kopcińskiego 22, Poland, 90-153
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Layout table for investigator information
Principal Investigator: Piotr Kuna, MD Medical University Lodz

Layout table for additonal information
Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT02119234     History of Changes
Other Study ID Numbers: CCD-05993AA1-04
2013-003770-27 ( EudraCT Number )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Glycopyrrolate
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
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists