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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176903
• Other study ID #: CCD-0916-PR-0032
• Secondary ID: 2010-018668-18
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2021
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and the efficacy of Glycopyrrolate as pMDI after single and repeated administration.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Glycopyrrolate
pressurized metered dose inhaler
• Tiotropium
inhalation powder, hard capsule
• placebo
pressurized metered dose inhaler

Locations

Country	Name	City	State
United Kingdom	Medicines Evaluation Unit	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 24 hours after single administration
Primary	Lung function (trough FEV1)	This primary variable is for the Part 2 of the study.	12 hours post dose after repeated administration
Secondary	Lung function	for Part 1 of the study	up to 24 hours post dose
Secondary	Lung function (other parameters)	for Part 2 of the study	up to 12 hours after repated administration
Secondary	Body plethysmography	for Part 2 of the study	up tp 12 hours after repeated administration
Secondary	Pharmacokinetics	Pharmacokinetics in plasma and urine. For Part 2 of the study.	up to 12 hours after single and repeated administration
Secondary	Safety	Adverse events, Vital signs, ECG parameters, 24-hour ECG holter recording. For Part 2 of the study.	up to 12 hours after single and repeated administration

External Links

•   CSR Synopsis available in the CHIESI Clinical Study Register
•   Study Record on EU Clinical Trials Register including results