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

NCT01176903 | Completed Phase 1

• 2 other identifiers: CCD-0916-PR-00322010-018668-18
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (2)

• 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

• Lung function (trough FEV1)

  This primary variable is for the Part 2 of the study.

  12 hours post dose after repeated administration

Secondary Outcomes (5)

• Lung function

  up to 24 hours post dose

• Lung function (other parameters)

  up to 12 hours after repated administration

• Body plethysmography

  up tp 12 hours after repeated administration

• Pharmacokinetics

  up to 12 hours after single and repeated administration

• Safety

  up to 12 hours after single and repeated administration

Study Arms (11)

Glyco SD1

EXPERIMENTAL

Single administration of Glyco pMDI dose level 1

Drug: Glycopyrrolate

Glyco SD2

EXPERIMENTAL

Single administration of Glyco pMDI dose level 2

Drug: Glycopyrrolate

Glyco SD3

EXPERIMENTAL

Single administration of Glyco pMDI dose level 3

Drug: Glycopyrrolate

Glyco SD4

EXPERIMENTAL

Single administration of Glyco pMDI dose level 4

Drug: Glycopyrrolate

Glyco SD5

EXPERIMENTAL

Single administration of Glyco pMDI dose level 5

Drug: Glycopyrrolate

Placebo SP

PLACEBO COMPARATOR

Single administration of Placebo pMDI

Drug: placebo

Glyco MD1

EXPERIMENTAL

Multiple administration of Glyco pMDI dose level 1

Drug: Glycopyrrolate

Glyco MD2

EXPERIMENTAL

Multiple administration of Glyco pMDI dose level 2

Drug: Glycopyrrolate

Glyco MD3

EXPERIMENTAL

Multiple administration of Glyco pMDI dose level 3

Drug: Glycopyrrolate

Placebo MP

PLACEBO COMPARATOR

Multiple administration of placebo pMDI

Drug: placebo

Tiotropium

ACTIVE COMPARATOR

Multiple administration of tiotropium

Drug: Tiotropium

Interventions

Glycopyrrolate DRUG

pressurized metered dose inhaler

Also known as: CHF 5259

Glyco MD1; Glyco MD2; Glyco MD3; Glyco SD1; Glyco SD2; Glyco SD3; Glyco SD4; Glyco SD5

Tiotropium DRUG

inhalation powder, hard capsule

Also known as: Spiriva

Tiotropium

placebo DRUG

pressurized metered dose inhaler

Placebo MP; Placebo SP

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

Related 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.

  PMID: 28744115 RESULT

Related Links

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Dave Singh, MD

  Medicines Evaluation Unit Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 6, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: August 1, 2011
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

GB (1)