Chronic Obstructive Pulmonary Disease (COPD)Phase 1/2GLY2NCT01176903
Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration
A Phase 1/2 study testing Glycopyrrolate and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety and the efficacy of Glycopyrrolate as pMDI after single and repeated administration. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Glycopyrrolate and Tiotropium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2010to Aug 2011
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females patients aged 40-75 years;
- Written informed consent obtained;
- Diagnosis of moderate-severe COPD, according to the GOLD guidelines;
- Current or ex-smokers with a smoking history of ≥ 10 pack-years
- Post bronchodilator FEV1 between 40% and 80% predicted values (40% ≤ FEV1 < 80%), documented at screening visit ;
- Post bronchodilator FEV1/Forced Vital Capacity (FEV1/FVC) ≤ 0.70 (absolute value) documented at screening visit;
- Airway reversibility of at least 100 mL within 30 to 45 minutes after inhalation of ipratropium 80µg.
Who cannot join
- History of chronic or seasonal allergy
- Blood eosinophil count above 600 per µl
- Clinically relevant findings on physical examination laboratory and ECG parameters at screening
- Occurrence of clinically relevant abnormalities in the 24-h Holter ECG recording at screening;
- Significant disease not related to COPD (eg. Myocardial infarction, stroke within the preceding 6 months);
- Respiratory tract infection (including upper tract) 4 weeks prior to study entry requiring changing treatment;
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- Patients requiring oxygen therapy on a daily basis for chronic hypoxemia;
- History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which is considered to be clinically significant by the investigator.
- Intolerance/hypersensitivity or any contra-indication to treatment with M3 Antagonist or any of the excipients contained in the formulations used in the study.
- History of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance.
- Patients treated with slow-release oral or parental corticosteroids 8 weeks prior to Screening Visit.
- Patients treated with tiotropium in the 10 days prior to the Screening Visit;
- Pregnant or lactating women and female or male subjects not willing to use an acceptable method of contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Cross-over Study to Investigate the Bronchodilator Efficacy and Safety After Single and Repeated Administrations of Different Doses of Glycopyrrolate Via pMDI in Moderate to Severe COPD Patients.
The purpose of this study is to evaluate the safety and the efficacy of Glycopyrrolate as pMDI after single and repeated administration.
Read the detailed description
The study is divided into two parts:
- Part 1 will be conducted according to a single-centre, randomized, double-blind, placebo-controlled, single-dose escalation, alternating crossover design in two groups of COPD patients.
Treatments to be administered on Part 1 (SD1, SD2, SD3, SD4, SD5, SP). The primary objective of Part 1 is the evaluation of the safety and tolerability of Glyco after single administration.
- Part 2 will be conducted according to a single-centre, randomized, double-blind, placebo-controlled, 4-period, 4-treatment, repeated dose cross-over design followed by an open-label extension period with tiotropium.
Treatments administered on Part 2 (MD1, MD2, MD3, MP, Tiotropium). On the last treatment day in the morning, Formoterol 12 µg will be administered to all patients on top of placebo or Glyco or Tiotropium.
The primary objective of Part 2 is the evaluation of the efficacy of Glyco after repeated administration.
Part 2 will start after a safety review of the results obtained from Part 1.
- Being tested
- Glycopyrrolate, Tiotropium, 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.
GlycopyrrolateDrug
Also called CHF 5259
pressurized metered dose inhaler
TiotropiumDrug
Also called Spiriva
inhalation powder, hard capsule
placeboDrug
pressurized metered dose inhaler
| Study group | Role | What they receive |
|---|---|---|
| Glyco SD1 | Experimental | Single administration of Glyco pMDI dose level 1 Receives: Drug: Glycopyrrolate |
| Glyco SD2 | Experimental | Single administration of Glyco pMDI dose level 2 Receives: Drug: Glycopyrrolate |
| Glyco SD3 | Experimental | Single administration of Glyco pMDI dose level 3 Receives: Drug: Glycopyrrolate |
| Glyco SD4 | Experimental | Single administration of Glyco pMDI dose level 4 Receives: Drug: Glycopyrrolate |
| Glyco SD5 | Experimental | Single administration of Glyco pMDI dose level 5 Receives: Drug: Glycopyrrolate |
| Placebo SP | Placebo comparator | Single administration of Placebo pMDI Receives: Drug: placebo |
| Glyco MD1 | Experimental | Multiple administration of Glyco pMDI dose level 1 Receives: Drug: Glycopyrrolate |
| Glyco MD2 | Experimental | Multiple administration of Glyco pMDI dose level 2 Receives: Drug: Glycopyrrolate |
| Glyco MD3 | Experimental | Multiple administration of Glyco pMDI dose level 3 Receives: Drug: Glycopyrrolate |
| Placebo MP | Placebo comparator | Multiple administration of placebo pMDI Receives: Drug: placebo |
| Tiotropium | Active comparator | Multiple administration of tiotropium Receives: Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Adverse events, vital signs, ECG parameters, 24-hours ECG holter recording, clinical laboratory abnormalities.
This primary outcome is for the Part 1 of the study.
Measured: Up to 24 hours after single administration
Lung function (trough FEV1)
This primary variable is for the Part 2 of the study.
Measured: 12 hours post dose after repeated administration
Secondary outcomes (5)
Lung function
for Part 1 of the study
Measured: up to 24 hours post dose
Lung function (other parameters)
for Part 2 of the study
Measured: up to 12 hours after repated administration
Body plethysmography
for Part 2 of the study
Measured: up tp 12 hours after repeated administration
Pharmacokinetics
Pharmacokinetics in plasma and urine. For Part 2 of the study.
Measured: up to 12 hours after single and repeated administration
Safety
Adverse events, Vital signs, ECG parameters, 24-hour ECG holter recording. For Part 2 of the study.
Measured: up to 12 hours after single and repeated administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2010
- Study completionAug 2011
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 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, Medicines Evaluation Unit Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176903
- Sponsor's protocol ID
- CCD-0916-PR-0032
- Other IDs
- 2010-018668-18
- Acronym
- GLY2
- Status last verified
- Oct 2021
- First submitted
- 5 Aug 2010
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Singh D, Scuri M, Collarini S, Vezzoli S, Mariotti F, Muraro A, Acerbi D. Bronchodilator efficacy of extrafine glycopyrronium bromide: the Glyco 2 study. Int J Chron Obstruct Pulmon Dis. 2017 Jul 7;12:2001-2014. doi: 10.2147/COPD.S137659. eCollection 2017.
PubMed 28744115
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
- Randomized, Double-blind, Placebo-controlled, Cross-over Study to Investigate the Bronchodilator Efficacy and Safety After Single and Repeated Administrations of Different Doses of Glycopyrrolate Via pMDI in Moderate to Severe COPD Patients.
- ClinicalTrials.gov ID
- NCT01176903
- Acronym / sponsor ID
- GLY2 / CCD-0916-PR-0032
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Aug 2010 (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 purpose of this study is to evaluate the safety and the efficacy of Glycopyrrolate as pMDI after single and repeated administration.
Detailed description
The study is divided into two parts:
- Part 1 will be conducted according to a single-centre, randomized, double-blind, placebo-controlled, single-dose escalation, alternating crossover design in two groups of COPD patients.
Treatments to be administered on Part 1 (SD1, SD2, SD3, SD4, SD5, SP). The primary objective of Part 1 is the evaluation of the safety and tolerability of Glyco after single administration.
- Part 2 will be conducted according to a single-centre, randomized, double-blind, placebo-controlled, 4-period, 4-treatment, repeated dose cross-over design followed by an open-label extension period with tiotropium.
Treatments administered on Part 2 (MD1, MD2, MD3, MP, Tiotropium). On the last treatment day in the morning, Formoterol 12 µg will be administered to all patients on top of placebo or Glyco or Tiotropium.
The primary objective of Part 2 is the evaluation of the efficacy of Glyco after repeated administration.
Part 2 will start after a safety review of the results obtained from Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Glyco SD1 | Experimental | Drug: GlycopyrrolateSingle administration of Glyco pMDI dose level 1 |
| Glyco SD2 | Experimental | Drug: GlycopyrrolateSingle administration of Glyco pMDI dose level 2 |
| Glyco SD3 | Experimental | Drug: GlycopyrrolateSingle administration of Glyco pMDI dose level 3 |
| Glyco SD4 | Experimental | Drug: GlycopyrrolateSingle administration of Glyco pMDI dose level 4 |
| Glyco SD5 | Experimental | Drug: GlycopyrrolateSingle administration of Glyco pMDI dose level 5 |
| Placebo SP | Placebo comparator | Drug: placeboSingle administration of Placebo pMDI |
| Glyco MD1 | Experimental | Drug: GlycopyrrolateMultiple administration of Glyco pMDI dose level 1 |
| Glyco MD2 | Experimental | Drug: GlycopyrrolateMultiple administration of Glyco pMDI dose level 2 |
| Glyco MD3 | Experimental | Drug: GlycopyrrolateMultiple administration of Glyco pMDI dose level 3 |
| Placebo MP | Placebo comparator | Drug: placeboMultiple administration of placebo pMDI |
| Tiotropium | Active comparator | Drug: TiotropiumMultiple administration of tiotropium |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females patients aged 40-75 years;
- Written informed consent obtained;
- Diagnosis of moderate-severe COPD, according to the GOLD guidelines;
- Current or ex-smokers with a smoking history of ≥ 10 pack-years
- Post bronchodilator FEV1 between 40% and 80% predicted values (40% ≤ FEV1 < 80%), documented at screening visit ;
Key exclusion criteria (13 listed)
- History of chronic or seasonal allergy
- Blood eosinophil count above 600 per µl
- Clinically relevant findings on physical examination laboratory and ECG parameters at screening
- Occurrence of clinically relevant abnormalities in the 24-h Holter ECG recording at screening;
- Significant disease not related to COPD (eg. Myocardial infarction, stroke within the preceding 6 months);
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: CHF 5259pressurized metered dose inhaler | Drug | Glyco MD1, Glyco MD2, Glyco MD3, Glyco SD1, Glyco SD2, Glyco SD3, Glyco SD4, Glyco SD5 |
| TiotropiumAlso: Spirivainhalation powder, hard capsule | Drug | Tiotropium |
| placebopressurized metered dose inhaler | Drug | Placebo MP, Placebo SP |
Primary outcome
Safety
Time frame: Up to 24 hours after single administration
Adverse events, vital signs, ECG parameters, 24-hours ECG holter recording, clinical laboratory abnormalities. This primary outcome is for the Part 1 of the study.
Lung function (trough FEV1)
Time frame: 12 hours post dose after repeated administration
This primary variable is for the Part 2 of the study.
5 secondary outcomes
Lung function
Time frame: up to 24 hours post dose
Lung function (other parameters)
Time frame: up to 12 hours after repated administration
Body plethysmography
Time frame: up tp 12 hours after repeated administration
Pharmacokinetics
Time frame: up to 12 hours after single and repeated administration
Safety
Time frame: up to 12 hours after single and repeated 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.
- Results publication: PubMed 28744115Singh D, Scuri M, Collarini S, Vezzoli S, Mariotti F, Muraro A, Acerbi D. Bronchodilator efficacy of extrafine glycopyrronium bromide: the Glyco 2 study. Int J Chron Obstruct Pulmon Dis. 2017 Jul 7;12:2001-2014. doi: 10.2147/COPD.S137659. eCollection 2017.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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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
Medicines Evaluation Unit Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Glycopyrrolate and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), 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 7 inclusion and 13 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. 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 combined 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.
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?
Safety (time frame: Up to 24 hours after single 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?
On the ClinicalTrials.gov record for NCT01176903, 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.