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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 January 2022 |
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Main ID: |
EUCTR2010-018668-18-BE |
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Date of registration:
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18/05/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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.
(GLYCO 2)
- GLY2
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Scientific title:
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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.
(GLYCO 2)
- GLY2 |
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Date of first enrolment:
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22/06/2010 |
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Target sample size:
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64 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018668-18 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: yes
Other trial design description: PART I single-dose, PART II repeated dose
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria:
Males and females patients aged 40-75 years;
2. Written informed consent obtained before the first trial related activity.
3. Diagnosis of moderate-severe COPD, according to the GOLD guidelines (2009);
4. Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
5. Body Mass Index (BMI) between 18.0 and 35 kg/m2;
6. Current or ex-smokers with a smoking history of = 10 pack years (e.g. = 20 cigarettes per day for 10 years and 40 cigarettes per day for 5 years);
7. Vital signs (systolic and diastolic blood pressure and heart rate) within the following ranges : 90 = SBP = 160; 50 = DBP =90; 50 = HR = 100);
8. Electrocardiogram (ECG) (12 lead) with computerized protocol interpretation considered as normal (120 ms = PR = 200 ms, QRS = 120 ms, QTcF = 450 ms). Minor deviations are acceptable provided that they are not judged clinically significant by the cardiologist;
9. Post bronchodilator FEV1 between 40% and 80% predicted values (40% = FEV1 = 80%), documented at screening visit ;
10. Post bronchodilator FEV1/Forced Vital Capacity (FEV1/FVC) = 0.70 (absolute value) documented at screening visit;
11. Airway reversibility of at least 100 mL within 30 to 45 minutes after inhalation of ipratropium 80 µg (for Part 2: historical reversibility is acceptable for patients who performed Part 1). If the reversibility criteria are not met and if the investigator deems it appropriate, the testing can be repeated once. This requirement must be met after re-testing during run-in period at least 24h prior to randomisation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
History of chronic or seasonal allergy
2. Blood eosinophil count above 0.6 x 10^9/L.
3. Clinically relevant findings on physical examination, laboratory or ECG parameters at screening.
4. Occurrence of one of the following 24-h Holter ECG abnormalities at screening:
a. More than 200 ventricular ectopics in 24 hours.
b. Ventricular tachycardia;
c. Second degree heart block.
d. Sustained cardiac arrhythmias (atrial fibrillation, SVT, complete heart block).
e. Any symptomatic arrhythmia (except isolated extra systoles)
f. Sinus pauses = 2.5 s
5. Significant disease not related to COPD (eg. Myocardial infarction, stroke within the preceding 6 months)
6. Respiratory tract infection (including upper tract) 4 weeks prior to Screening Visit requiring changing treatment
7. Patients requiring oxygen therapy on a daily basis for chronic hypoxemia
8. Patients who have been hospitalized in the previous 6 weeks prior to screening visit
9. Having received an investigational product within the last 8 weeks before the Screening Visit.
10. Inability to comply with study procedures or with study treatment intake, including inability to be trained with Vitalograph AIM.
11. 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.
12. Intolerance/hypersensitivity or any contra-indication to treatment with M3 Antagonist or any of the excipients contained in the formulations used in the study.
13. History of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance.
14. Patients who have undergone major surgery in the 12 weeks before the Screening Visit.
15. Patients treated with oral (slow-release included) or parental steroids 8 weeks prior to Screening Visit
16. Patients treated with oral ß2-adrenergics, antihistamines, or theophyllines 1 month prior to Screening Visit or enzyme inducing or inhibiting drugs 2 months before the first administration.
17. Patients treated with tiotropium in the 10 days prior to the Screening Visit.
18. Female patients: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of the gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test (> 5 mIU/mL. Serum pregnancy test to be done at Screening for verification). Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or are using an acceptable method of contraception.
Male patients: must be sterile or they or their partner must be willing to use an approved method of contraception from the time of dose administration and until 30 days after the last dose of study. Patients must not donate sperm for 30 days after the last dose of study drug. A reliable method of contraception for male and female subjects (or their partner), depending on the method, can be one or more of the following ones:
a) Surgical sterilization (i.e. bilateral tubal ligation, hysterectomy for females; vasectomy for males)
b) Hormonal contraception (implantable, patch, oral)
c) Double-barrier methods (any double combination of: IUD, male or female condom, diaphragm, sponge, cervical cap, con
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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COPD
MedDRA version: 12.1
Level: LLT
Classification code 10010952
Term: COPD
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Intervention(s)
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Product Name: Glyco pMDI
Product Code: CHF 5259 pMDI
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: glycopyrrolate bromide
CAS Number: 596-51-0
Current Sponsor code: CHF 5259.02
Other descriptive name: Glyco
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Pressurised inhalation, solution
Route of administration of the placebo: Inhalation use
Trade Name: Spiriva
Product Name: Spiriva 18 µg inhalation powder, hard capsule
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: TIOTROPIUM BROMIDE
CAS Number: 139404481
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 18-
Product Name: Glyco pMDI
Product Code: CHF 5259 pMDI
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: glycopyrrolate bromide
CAS Number: 596-51-0
Current Sponsor code: CHF 5259.02
Other descriptive name: Glyco
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 12.5-
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Primary Outcome(s)
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Primary end point(s): Part I
Adverse Events (AEs) and Adverse Drug Reactions (ADRs), including occurrence of paradoxical bronchospasm;
vital signs: heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP)
12-lead ECG parameters: ventricular heart rate, PR, QRS, QT, QTcB, QTcF;
abnormal findings on 12-lead ECG;
24 h ECG Holter recordings;
clinical chemistry and hematology, urinalysis.
Part II
Core periods: trough FEV1 at 12 h post-dose on Day 7 (before evening administration) defined as the mean of two measurements at 12 h and 12.5 h post-dose.
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Secondary Objective: PART I
• To assess the bronchodilator efficacy of single administration of Glyco pMDI at 5 dose levels by comparison with placebo in patients with moderate to severe COPD.
PART II
• To evaluate the duration of bronchodilation
• To assess the safety and tolerability of repeated doses of Glyco pMDI.
• To evaluate the pharmacokinetic profile after single and repeated administration of Glyco pMDI.
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Main Objective: PART I
• To assess the safety and tolerability of single administration of Glyco pMDI at 5 dose levels in patients with moderate to severe COPD
PART II
• To assess the bronchodilator efficacy of Glyco pMDI at 3 dose levels by comparison with placebo in patients with moderate to severe COPD after repeated administration
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Secondary ID(s)
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CCD-0916-PR-0032
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 09/06/2010
Contact:
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