Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration
NCT ID: NCT01176903
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
65 participants
INTERVENTIONAL
2010-08-31
2011-08-31
Brief Summary
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Detailed Description
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\- 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Glyco SD1
Single administration of Glyco pMDI dose level 1
Glycopyrrolate
pressurized metered dose inhaler
Glyco SD2
Single administration of Glyco pMDI dose level 2
Glycopyrrolate
pressurized metered dose inhaler
Glyco SD3
Single administration of Glyco pMDI dose level 3
Glycopyrrolate
pressurized metered dose inhaler
Glyco SD4
Single administration of Glyco pMDI dose level 4
Glycopyrrolate
pressurized metered dose inhaler
Glyco SD5
Single administration of Glyco pMDI dose level 5
Glycopyrrolate
pressurized metered dose inhaler
Placebo SP
Single administration of Placebo pMDI
placebo
pressurized metered dose inhaler
Glyco MD1
Multiple administration of Glyco pMDI dose level 1
Glycopyrrolate
pressurized metered dose inhaler
Glyco MD2
Multiple administration of Glyco pMDI dose level 2
Glycopyrrolate
pressurized metered dose inhaler
Glyco MD3
Multiple administration of Glyco pMDI dose level 3
Glycopyrrolate
pressurized metered dose inhaler
Placebo MP
Multiple administration of placebo pMDI
placebo
pressurized metered dose inhaler
Tiotropium
Multiple administration of tiotropium
Tiotropium
inhalation powder, hard capsule
Interventions
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Glycopyrrolate
pressurized metered dose inhaler
Tiotropium
inhalation powder, hard capsule
placebo
pressurized metered dose inhaler
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
75 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Dave Singh, MD
Role: PRINCIPAL_INVESTIGATOR
Medicines Evaluation Unit Ltd
Locations
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Medicines Evaluation Unit
Manchester, , United Kingdom
Countries
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References
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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.
Related Links
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Study Record on EU Clinical Trials Register including results
CSR Synopsis available in the CHIESI Clinical Study Register
Other Identifiers
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2010-018668-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD-0916-PR-0032
Identifier Type: -
Identifier Source: org_study_id