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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01176903
First received: August 5, 2010
Last updated: December 14, 2011
Last verified: December 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
 Drug: Glycopyrrolate
Drug: Tiotropium
Drug: placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Safety [ Time Frame: Up to 24 hours after single administration ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    This primary variable is for the Part 2 of the study.


Secondary Outcome Measures:
  • Lung function [ Time Frame: up to 24 hours post dose ] [ Designated as safety issue: No ]
    for Part 1 of the study

  • Lung function (other parameters) [ Time Frame: up to 12 hours after repated administration ] [ Designated as safety issue: No ]
    for Part 2 of the study

  • Body plethysmography [ Time Frame: up tp 12 hours after repeated administration ] [ Designated as safety issue: No ]
    for Part 2 of the study

  • Pharmacokinetics [ Time Frame: up to 12 hours after single and repeated administration ] [ Designated as safety issue: No ]
    Pharmacokinetics in plasma and urine. For Part 2 of the study.

  • Safety [ Time Frame: up to 12 hours after single and repeated administration ] [ Designated as safety issue: Yes ]
    Adverse events, Vital signs, ECG parameters, 24-hour ECG holter recording. For Part 2 of the study.


Enrollment: 65
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glyco SD1
Single administration of Glyco pMDI dose level 1
 Drug: Glycopyrrolate
pressurized metered dose inhaler
Other Name: CHF 5259
Experimental: Glyco SD2
Single administration of Glyco pMDI dose level 2
 Drug: Glycopyrrolate
pressurized metered dose inhaler
Other Name: CHF 5259
Experimental: Glyco SD3
Single administration of Glyco pMDI dose level 3
 Drug: Glycopyrrolate
pressurized metered dose inhaler
Other Name: CHF 5259
Experimental: Glyco SD4
Single administration of Glyco pMDI dose level 4
 Drug: Glycopyrrolate
pressurized metered dose inhaler
Other Name: CHF 5259
Experimental: Glyco SD5
Single administration of Glyco pMDI dose level 5
 Drug: Glycopyrrolate
pressurized metered dose inhaler
Other Name: CHF 5259
Placebo Comparator: Placebo SP
Single administration of Placebo pMDI
 Drug: placebo
pressurized metered dose inhaler
Experimental: Glyco MD1
Multiple administration of Glyco pMDI dose level 1
 Drug: Glycopyrrolate
pressurized metered dose inhaler
Other Name: CHF 5259
Experimental: Glyco MD2
Multiple administration of Glyco pMDI dose level 2
 Drug: Glycopyrrolate
pressurized metered dose inhaler
Other Name: CHF 5259
Experimental: Glyco MD3
Multiple administration of Glyco pMDI dose level 3
 Drug: Glycopyrrolate
pressurized metered dose inhaler
Other Name: CHF 5259
Placebo Comparator: Placebo MP
Multiple administration of placebo pMDI
 Drug: placebo
pressurized metered dose inhaler
Active Comparator: Tiotropium
Multiple administration of tiotropium
 Drug: Tiotropium
inhalation powder, hard capsule
Other Name: Spiriva

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176903

Locations
United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Dave Singh, MD Medicines Evaluation Unit Ltd
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01176903     History of Changes
Other Study ID Numbers: CCD-0916-PR-0032, 2010-018668-18
Study First Received: August 5, 2010
Last Updated: December 14, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Glycopyrrolate
Tiotropium
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on June 17, 2013