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Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration (GLY2)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Glycopyrrolate
Tiotropium
placebo
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Sites / Locations

  • Medicines Evaluation Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

Glyco SD1

Glyco SD2

Glyco SD3

Glyco SD4

Glyco SD5

Placebo SP

Glyco MD1

Glyco MD2

Glyco MD3

Placebo MP

Tiotropium

Arm Description

Single administration of Glyco pMDI dose level 1

Single administration of Glyco pMDI dose level 2

Single administration of Glyco pMDI dose level 3

Single administration of Glyco pMDI dose level 4

Single administration of Glyco pMDI dose level 5

Single administration of Placebo pMDI

Multiple administration of Glyco pMDI dose level 1

Multiple administration of Glyco pMDI dose level 2

Multiple administration of Glyco pMDI dose level 3

Multiple administration of placebo pMDI

Multiple administration of tiotropium

Outcomes

Primary Outcome Measures

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.
Lung function (trough FEV1)
This primary variable is for the Part 2 of the study.

Secondary Outcome Measures

Lung function
for Part 1 of the study
Lung function (other parameters)
for Part 2 of the study
Body plethysmography
for Part 2 of the study
Pharmacokinetics
Pharmacokinetics in plasma and urine. For Part 2 of the study.
Safety
Adverse events, Vital signs, ECG parameters, 24-hour ECG holter recording. For Part 2 of the study.

Full Information

First Posted
August 5, 2010
Last Updated
October 28, 2021
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01176903
Brief Title
Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration
Acronym
GLY2
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glyco SD1
Arm Type
Experimental
Arm Description
Single administration of Glyco pMDI dose level 1
Arm Title
Glyco SD2
Arm Type
Experimental
Arm Description
Single administration of Glyco pMDI dose level 2
Arm Title
Glyco SD3
Arm Type
Experimental
Arm Description
Single administration of Glyco pMDI dose level 3
Arm Title
Glyco SD4
Arm Type
Experimental
Arm Description
Single administration of Glyco pMDI dose level 4
Arm Title
Glyco SD5
Arm Type
Experimental
Arm Description
Single administration of Glyco pMDI dose level 5
Arm Title
Placebo SP
Arm Type
Placebo Comparator
Arm Description
Single administration of Placebo pMDI
Arm Title
Glyco MD1
Arm Type
Experimental
Arm Description
Multiple administration of Glyco pMDI dose level 1
Arm Title
Glyco MD2
Arm Type
Experimental
Arm Description
Multiple administration of Glyco pMDI dose level 2
Arm Title
Glyco MD3
Arm Type
Experimental
Arm Description
Multiple administration of Glyco pMDI dose level 3
Arm Title
Placebo MP
Arm Type
Placebo Comparator
Arm Description
Multiple administration of placebo pMDI
Arm Title
Tiotropium
Arm Type
Active Comparator
Arm Description
Multiple administration of tiotropium
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Other Intervention Name(s)
CHF 5259
Intervention Description
pressurized metered dose inhaler
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Other Intervention Name(s)
Spiriva
Intervention Description
inhalation powder, hard capsule
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
pressurized metered dose inhaler
Primary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
Up to 24 hours after single administration
Title
Lung function (trough FEV1)
Description
This primary variable is for the Part 2 of the study.
Time Frame
12 hours post dose after repeated administration
Secondary Outcome Measure Information:
Title
Lung function
Description
for Part 1 of the study
Time Frame
up to 24 hours post dose
Title
Lung function (other parameters)
Description
for Part 2 of the study
Time Frame
up to 12 hours after repated administration
Title
Body plethysmography
Description
for Part 2 of the study
Time Frame
up tp 12 hours after repeated administration
Title
Pharmacokinetics
Description
Pharmacokinetics in plasma and urine. For Part 2 of the study.
Time Frame
up to 12 hours after single and repeated administration
Title
Safety
Description
Adverse events, Vital signs, ECG parameters, 24-hour ECG holter recording. For Part 2 of the study.
Time Frame
up to 12 hours after single and repeated administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dave Singh, MD
Organizational Affiliation
Medicines Evaluation Unit Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicines Evaluation Unit
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28744115
Citation
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.
Results Reference
result
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2010-018668-18
Description
Study Record on EU Clinical Trials Register including results
URL
https://www.chiesi.com/clinic/CSR_Synopsis_CCD-0916-PR-0032.pdf
Description
CSR Synopsis available in the CHIESI Clinical Study Register

Learn more about this trial

Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration

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