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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

August 5, 2010
December 14, 2011
August 2010
November 2010   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01176903 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
  • Drug: Glycopyrrolate
    pressurized metered dose inhaler
    Other Name: CHF 5259
  • Drug: Tiotropium
    inhalation powder, hard capsule
    Other Name: Spiriva
  • Drug: placebo
    pressurized metered dose inhaler
  • Experimental: Glyco SD1
    Single administration of Glyco pMDI dose level 1
    Intervention: Drug: Glycopyrrolate
  • Experimental: Glyco SD2
    Single administration of Glyco pMDI dose level 2
    Intervention: Drug: Glycopyrrolate
  • Experimental: Glyco SD3
    Single administration of Glyco pMDI dose level 3
    Intervention: Drug: Glycopyrrolate
  • Experimental: Glyco SD4
    Single administration of Glyco pMDI dose level 4
    Intervention: Drug: Glycopyrrolate
  • Experimental: Glyco SD5
    Single administration of Glyco pMDI dose level 5
    Intervention: Drug: Glycopyrrolate
  • Placebo Comparator: Placebo SP
    Single administration of Placebo pMDI
    Intervention: Drug: placebo
  • Experimental: Glyco MD1
    Multiple administration of Glyco pMDI dose level 1
    Intervention: Drug: Glycopyrrolate
  • Experimental: Glyco MD2
    Multiple administration of Glyco pMDI dose level 2
    Intervention: Drug: Glycopyrrolate
  • Experimental: Glyco MD3
    Multiple administration of Glyco pMDI dose level 3
    Intervention: Drug: Glycopyrrolate
  • Placebo Comparator: Placebo MP
    Multiple administration of placebo pMDI
    Intervention: Drug: placebo
  • Active Comparator: Tiotropium
    Multiple administration of tiotropium
    Intervention: Drug: Tiotropium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
August 2011
November 2010   (final data collection date for primary outcome measure)

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.
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01176903
CCD-0916-PR-0032, 2010-018668-18
No
Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A.
Not Provided
Principal Investigator: Dave Singh, MD Medicines Evaluation Unit Ltd
Chiesi Farmaceutici S.p.A.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP