COPDPhase 1TRIPLE 1NCT01398111
Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers
A Phase 1 study testing Glycopyrrolate + Formoterol, Glycopyrrolate and Formoterol in people with COPD, run by Chiesi Farmaceutici S.p.A. at 1 site in Belgium.
Trial summary
This study will be carried out in healthy volunteers with the primary objective to evaluate the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised metered dose inhaler (pMDI). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Glycopyrrolate + Formoterol, Glycopyrrolate and Formoterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- May 2011to Aug 2011
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females healthy volunteers aged 18-65 years will be included in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Clinical Pharmacology Unit - SGS Life Science Services
Antwerp, Lange Beeldekensstraat 267, 2060
About this study
Official title: Open-label, Randomized, Single-dose, Placebo-controlled, 4-way Crossover Study to Investigate the Pharmacokinetic Interaction of Glycopyrrolate and Formoterol in Healthy Subjects.
This study will be carried out in healthy volunteers with the primary objective to evaluate the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised metered dose inhaler (pMDI).
- Conditions
- COPD
- Being tested
- Glycopyrrolate + Formoterol, Glycopyrrolate, Formoterol, 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.
Glycopyrrolate + FormoterolDrug
glycopyrrolate pMDI + formoterol pMDI
GlycopyrrolateDrug
glycopyrrolate pMDI
FormoterolDrug
formoterol pMDI
PlaceboDrug
placebo pMDI
| Study group | Role | What they receive |
|---|---|---|
| Treatment R2 | Active comparator | Not described Receives: Drug: Formoterol |
| Treatment R1 | Active comparator | Not described Receives: Drug: Glycopyrrolate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Treatment T | Experimental | Not described Receives: Drug: Glycopyrrolate + Formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: formoterol and glyco AUC0-t
Area under the plasma concentration curve observed from administration up to the last measurable concentration.
Measured: from pre-dose to 32 hours after administration
Pharmacokinetics: formoterol and glyco Cmax
Maximum plasma concentration
Measured: from pre-dose to 32 hours after administration
Secondary outcomes (6)
Additional pharmacokinetic variables
Plasma Glyco AUC0-30min, AUC0-32h, AUC0-inf, tmax and t1/2 - Plasma Formoterol AUC0-30min, AUC0-24h, AUC0-inf, tmax and t1/2.
Measured: from pre-dose to 32 hours post dose
Serum potassium
Serum potassium Cmin, tmin and AUC0-24h
Measured: From pre-dose to 24 hours after administration
Plasma glucose
Plasma glucose Cmax, tmax and AUC0-24h
Measured: from pre-dose to 24 hours after administration
Lung function
FEV1 in order to assess potential occurrence of paradoxical bronchospasm
Measured: from pre-dose to 1 hour after administration
Vital signs
heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP).
Measured: from pre-dose to 24 hours after administration
ECG
12-lead ECG parameters: HR, RR, PR, QRS, QT, QTcB, QTcF
Measured: from pre-dose to 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011
- Study completionAug 2011
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lien Gheyle, MD, Principal investigator, Clinical Pharmacology Unit at SGS Life Sciences - Antwerpen (Belgium)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398111
- Sponsor's protocol ID
- CCD-1101-PR-0056
- Other IDs
- 2011-001552-11
- Acronym
- TRIPLE 1
- Status last verified
- Oct 2021
- First submitted
- 9 Jun 2011
- 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, Single-dose, Placebo-controlled, 4-way Crossover Study to Investigate the Pharmacokinetic Interaction of Glycopyrrolate and Formoterol in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01398111
- Acronym / sponsor ID
- TRIPLE 1 / CCD-1101-PR-0056
- Conditions
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Jul 2011 (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.
This study will be carried out in healthy volunteers with the primary objective to evaluate the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised metered dose inhaler (pMDI).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment R2 | Active comparator | Drug: Formoterol |
| Treatment R1 | Active comparator | Drug: Glycopyrrolate |
| Placebo | Placebo comparator | Drug: Placebo |
| Treatment T | Experimental | Drug: Glycopyrrolate + Formoterol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males and females healthy volunteers aged 18-65 years will be included in the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Glycopyrrolate + Formoterolglycopyrrolate pMDI + formoterol pMDI | Drug | Treatment T |
| Glycopyrrolateglycopyrrolate pMDI | Drug | Treatment R1 |
| Formoterolformoterol pMDI | Drug | Treatment R2 |
| Placeboplacebo pMDI | Drug | Placebo |
Primary outcome
Pharmacokinetics: formoterol and glyco AUC0-t
Time frame: from pre-dose to 32 hours after administration
Area under the plasma concentration curve observed from administration up to the last measurable concentration.
Pharmacokinetics: formoterol and glyco Cmax
Time frame: from pre-dose to 32 hours after administration
Maximum plasma concentration
6 secondary outcomes
Additional pharmacokinetic variables
Time frame: from pre-dose to 32 hours post dose
Serum potassium
Time frame: From pre-dose to 24 hours after administration
Plasma glucose
Time frame: from pre-dose to 24 hours after administration
Lung function
Time frame: from pre-dose to 1 hour after administration
Vital signs
Time frame: from pre-dose to 24 hours after administration
ECG
Time frame: from pre-dose to 24 hours after 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.
Lien Gheyle, MD principal investigator
Clinical Pharmacology Unit at SGS Life Sciences - Antwerpen (Belgium)
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 Glycopyrrolate + Formoterol, Glycopyrrolate and Formoterol in people with COPD, run by Chiesi Farmaceutici S.p.A. at 1 site in Belgium.
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 1 inclusion and 0 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 Belgium. 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?
Pharmacokinetics: formoterol and glyco AUC0-t (time frame: from pre-dose to 32 hours after administration). The study lists 2 primary outcomes in all. 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.