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OpenTrials
Completed

NCT Number: NCT02119234

Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical University in Lodz

Lodz, Ul. Kopcińskiego 22, 90-153, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beclometasone/formoterol/glycopyrrolate

Drug

Other names: CHF5993 pMDI

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study 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

Acronym: TRIPLE 4

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 21, 2014
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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