Pulmonary Disease, Chronic ObstructivePhase 2NCT01476813
Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
A Phase 2 study testing Glycopyrrolate and Comparator in people with Pulmonary Disease, Chronic Obstructive, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Glycopyrrolate and Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Jul 2013
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD over 40 years of age (30 to 60% post-bronchodilator FEV1 predictive value)
- Patients under Double
- Patients under triple therapy (for 1 Mo prior Screening)
Who cannot join
- Pregnant or lactating women
- Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or antibiotics, hospitalization
- concommitant diseases impacting feasibility or safety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Active-controlled, Cross-over Study to Assess Efficacy and Safety of 3 Free Doses of Glycopyrrolate With Beclomethasone/Formoterol pMDI for the Treatment of COPD Patients
dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.
Read the detailed description
A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 4-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF GLYCOPYRROLATE WITH FIXED COMBINATION BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL (FOSTER®) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Glycopyrrolate, Comparator
- 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.
GlycopyrrolateDrug
Also called Foster+GLyco 25
comparison of different dosages of drug
GlycopyrrolateDrug
Also called Foster+GLyco 50
comparison of different dosages of drug
GlycopyrrolateDrug
Also called Foster+GLyco 100
comparison of different dosages of drug
ComparatorDrug
Also called Foster
comparison of different dosages of drug versus comparator
| Study group | Role | What they receive |
|---|---|---|
| Glyco 25 | Experimental | BDP/FF (400/24 daily)+ Glyco 25µg daily Receives: Drug: Glycopyrrolate |
| Glyco 50 | Experimental | BDP/FF (400/24 daily)+ Glyco 50 µg daily Receives: Drug: Glycopyrrolate |
| Glyco 100 | Experimental | BDP/FF (400/24 daily)+ Glyco 100µg daily Receives: Drug: Glycopyrrolate |
| BDP/FF 400/24 | Active comparator | BDP/FF 400/24 Receives: Drug: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aera under curve FEV1 AUC 0-12h
Measured: day 1 and 7 of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionSep 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Singh, MD, Principal investigator, Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476813
- Sponsor's protocol ID
- CCD-1106-PR-0066
- Status last verified
- Oct 2021
- First submitted
- 18 Nov 2011
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information. Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
Publications
Singh D, Schroder-Babo W, Cohuet G, Muraro A, Bonnet-Gonod F, Petruzzelli S, Hoffmann M, Siergiejko Z; TRIDENT study investigators. The bronchodilator effects of extrafine glycopyrronium added to combination treatment with beclometasone dipropionate plus formoterol in COPD: A randomised crossover study (the TRIDENT study). Respir Med. 2016 May;114:84-90. doi: 10.1016/j.rmed.2016.03.018. Epub 2016 Mar 26.
PubMed 27109816
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
- A Randomized, Double-blind, Active-controlled, Cross-over Study to Assess Efficacy and Safety of 3 Free Doses of Glycopyrrolate With Beclomethasone/Formoterol pMDI for the Treatment of COPD Patients
- ClinicalTrials.gov ID
- NCT01476813
- Acronym / sponsor ID
- CCD-1106-PR-0066
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Nov 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.
dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.
Detailed description
A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 4-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF GLYCOPYRROLATE WITH FIXED COMBINATION BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL (FOSTER®) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Glyco 25 | Experimental | Drug: GlycopyrrolateBDP/FF (400/24 daily)+ Glyco 25µg daily |
| Glyco 50 | Experimental | Drug: GlycopyrrolateBDP/FF (400/24 daily)+ Glyco 50 µg daily |
| Glyco 100 | Experimental | Drug: GlycopyrrolateBDP/FF (400/24 daily)+ Glyco 100µg daily |
| BDP/FF 400/24 | Active comparator | Drug: ComparatorBDP/FF 400/24 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD over 40 years of age (30 to 60% post-bronchodilator FEV1 predictive value)
- Patients under Double
- Patients under triple therapy (for 1 Mo prior Screening)
Key exclusion criteria (3 listed)
- Pregnant or lactating women
- Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or antibiotics, hospitalization
- concommitant diseases impacting feasibility or safety
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 |
|---|---|---|
| GlycopyrrolateAlso: Foster+GLyco 25comparison of different dosages of drug | Drug | Glyco 25 |
| GlycopyrrolateAlso: Foster+GLyco 50comparison of different dosages of drug | Drug | Glyco 50 |
| GlycopyrrolateAlso: Foster+GLyco 100comparison of different dosages of drug | Drug | Glyco 100 |
| ComparatorAlso: Fostercomparison of different dosages of drug versus comparator | Drug | BDP/FF 400/24 |
Primary outcome
Aera under curve FEV1 AUC 0-12h
Time frame: day 1 and 7 of treatment period
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.
- Results publication: PubMed 27109816Singh D, Schroder-Babo W, Cohuet G, Muraro A, Bonnet-Gonod F, Petruzzelli S, Hoffmann M, Siergiejko Z; TRIDENT study investigators. The bronchodilator effects of extrafine glycopyrronium added to combination treatment with beclometasone dipropionate plus formoterol in COPD: A randomised crossover study (the TRIDENT study). Respir Med. 2016 May;114:84-90. doi: 10.1016/j.rmed.2016.03.018. Epub 2016 Mar 26.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information. Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
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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.
Dave Singh, MD principal investigator
Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glycopyrrolate and Comparator in people with Pulmonary Disease, Chronic Obstructive, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
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 3 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Aera under curve FEV1 AUC 0-12h (time frame: day 1 and 7 of treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01476813, which also lists 1 linked publication.
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.