COPDPhase 1TRIPLE 4NCT02119234
Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients
A Phase 1 study testing Beclometasone/formoterol/glycopyrrolate in people with COPD, run by Chiesi Farmaceutici S.p.A. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- COPD
- What is being tested?
- Beclometasone/formoterol/glycopyrrolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2014to Feb 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients
- smokers or ex-smokers
- post-bronchodilator FEV1 between 30 and 60% of predicted value
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- COPD
- Being tested
- Beclometasone/formoterol/glycopyrrolate, Placebo
- 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 CHF5993 pMDI
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CHF5993 pMDI + Spacer | Experimental | CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using Aerochamber Plus Flow-vu VHC spacer Receives: Drug: Beclometasone/formoterol/glycopyrrolate |
| CHF5993 pMDI | Active comparator | CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using standard actuator only Receives: Drug: Beclometasone/formoterol/glycopyrrolate |
| Placebo pMDI | Placebo comparator | Placebo pMDI x 4 inhalations Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of B17MP, formoterol and glycopyrrolate
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
Measured: Over 24 and 48h after single administration
Secondary outcomes (8)
Other pharmacokinetic parameters for formoterol, glycopyrrolate and B17MP in plasma
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
Measured: over 24 or 48h after single administration
Adverse events
from the signature of the informed consent until the follow-up phone call
Measured: over a period of 6 to 11 weeks
Lung function
FEV1
Measured: 30 min after single administration
plasma cortisol
cortisol AUC0-24h, Cmin and tmin
Measured: over 24 h after single administration
cortisol urinary excretion
cortisol excretion corrected and not corrected for creatinine
Measured: over 24 h after single administration
potassium plasma profile
potassium AUC0-24h, tmin and Cmin
Measured: over 24 h after single administration
Vital signs
systolic and diastolic blood pressure
Measured: over 24 h after single administration
ECG parameters
extracted from holter recording HR, QTcF, PR and 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 posted21 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 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 Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119234
- Sponsor's protocol ID
- CCD-05993AA1-04
- Other IDs
- 2013-003770-27
- Acronym
- TRIPLE 4
- Status last verified
- Oct 2021
- First submitted
- 11 Apr 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, 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
- ClinicalTrials.gov ID
- NCT02119234
- Acronym / sponsor ID
- TRIPLE 4 / CCD-05993AA1-04
- Conditions
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Apr 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHF5993 pMDI + Spacer | Experimental | Drug: Beclometasone/formoterol/glycopyrrolateCHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using Aerochamber Plus Flow-vu VHC spacer |
| CHF5993 pMDI | Active comparator | Drug: Beclometasone/formoterol/glycopyrrolateCHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using standard actuator only |
| Placebo pMDI | Placebo comparator | Drug: PlaceboPlacebo pMDI x 4 inhalations |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD patients
- smokers or ex-smokers
- post-bronchodilator FEV1 between 30 and 60% of predicted value
Key exclusion criteria (6 listed)
- 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
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: CHF5993 pMDI | Drug | CHF5993 pMDI, CHF5993 pMDI + Spacer |
| Placebo | Drug | Placebo pMDI |
Primary outcome
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
8 secondary outcomes
Other pharmacokinetic parameters for formoterol, glycopyrrolate and B17MP in plasma
Time frame: over 24 or 48h after single administration
Adverse events
Time frame: over a period of 6 to 11 weeks
Lung function
Time frame: 30 min after single administration
plasma cortisol
Time frame: over 24 h after single administration
cortisol urinary excretion
Time frame: over 24 h after single administration
potassium plasma profile
Time frame: over 24 h after single administration
Vital signs
Time frame: over 24 h after single administration
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 Lodz
1 site 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 COPD, run by Chiesi Farmaceutici S.p.A. at 1 site 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 3 inclusion and 6 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 1 site 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. Some participants in this study may receive a placebo. 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?
Area under the curve of B17MP, formoterol and glycopyrrolate (time frame: Over 24 and 48h 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.