Chronic Obstructive Pulmonary Disease (COPD)Phase 1TRIPLE10NCT02040597
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.
A Phase 1 study testing Beclometasone/Formoterol/Glycopyrrolate in people with Chronic Obstructive Pulmonary Disease (COPD), run by Chiesi Farmaceutici S.p.A. at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Beclometasone/Formoterol/Glycopyrrolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesPoland
- Study dates
- Jan 2014to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers and
- Subjects with mild, moderate and severe renal impairment
Who cannot join
- 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
Show all 9Show fewer
- clinically relevant concomitant disease that may introduce a risk for the subjects'safety
- presence of kidney stones
- dialysis
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Medical University in Lodz
Lodz, Ul. Kopcińskiego 22, 90-153
Biovirtus Research Site
Nadarzyn, Mokra 7, 05-830
About this study
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.
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.
- Being tested
- Beclometasone/Formoterol/Glycopyrrolate
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclometasone/Formoterol/GlycopyrrolateDrug
Also called CHF 5993 pMDI
| Study group | Role | What they receive |
|---|---|---|
| CHF5993 pMDI | Experimental | CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations Receives: Drug: Beclometasone/Formoterol/Glycopyrrolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycopyrrolate area under the curve (AUC)
AUC until the last quantifiable concentration (AUCt)
Measured: over 72 h after single administration
Secondary outcomes (8)
Glycopyrrolate other Pharmacokinetic parameters in plasma
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
Measured: Over 72 h after single administration
B17MP and Formoterol pharmacokinetic parameters in plasma
AUCt, AUC until 24 h post dose (AUC0-24h), AUCinf, Cmax, tmax, half-life, clearance
Measured: over 24 h after single administration
BDP pharmacokinetic parameters in plasma
AUCt, AUCinf, Cmax, tmax, half-life
Measured: over 24 h after single administration
Urine Glycopyrrolate excretion (Ae)
Measured: over 72 h after single administration
Urine formoterol excretion (Ae)
Measured: Over 24 h after single administration
Adverse events
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
Measured: A period of 3 to 7 weeks (from screening visit to follow-up phone call)
Vital signs
systolic and diastolic blood pressure
Measured: over 24 h after single administration
Electrocardiogram (ECG) parameters
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)
Measured: over 24 h after single administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Piotr Kuna, MD, Principal investigator, Medical University in LodzKasia Jarus-Dziedzic, MD, Principal investigator, Biovirtus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040597
- Sponsor's protocol ID
- CCD-05993AA1-10
- Other IDs
- 2013-002140-91
- Acronym
- TRIPLE10
- Status last verified
- Oct 2021
- First submitted
- 9 Jan 2014
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02040597
- Acronym / sponsor ID
- TRIPLE10 / CCD-05993AA1-10
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHF5993 pMDI | Experimental | Drug: Beclometasone/Formoterol/GlycopyrrolateCHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers and
- Subjects with mild, moderate and severe renal impairment
Key exclusion criteria (9 listed)
- pregnant or lactating women
- positive HIV and hepatitis serology
- history of drug abuse
- history of hypersensitivity to the products used in the trial
- smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beclometasone/Formoterol/GlycopyrrolateAlso: CHF 5993 pMDI | Drug | CHF5993 pMDI |
Primary outcome
Glycopyrrolate area under the curve (AUC)
Time frame: over 72 h after single administration
AUC until the last quantifiable concentration (AUCt)
8 secondary outcomes
Glycopyrrolate other Pharmacokinetic parameters in plasma
Time frame: Over 72 h after single administration
B17MP and Formoterol pharmacokinetic parameters in plasma
Time frame: over 24 h after single administration
BDP pharmacokinetic parameters in plasma
Time frame: over 24 h after single administration
Urine Glycopyrrolate excretion (Ae)
Time frame: over 72 h after single administration
Urine formoterol excretion (Ae)
Time frame: Over 24 h after single administration
Adverse events
Time frame: A period of 3 to 7 weeks (from screening visit to follow-up phone call)
Vital signs
Time frame: over 24 h after single administration
Electrocardiogram (ECG) parameters
Time frame: over 24 h after single administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Kuna, MD principal investigator
Medical University in Lodz
Kasia Jarus-Dziedzic, MD principal investigator
Biovirtus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Beclometasone/Formoterol/Glycopyrrolate in people with Chronic Obstructive Pulmonary Disease (COPD), run by Chiesi Farmaceutici S.p.A. at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycopyrrolate area under the curve (AUC) (time frame: over 72 h after single administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.