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
- Conditions
- MedDRA version: 12.1Level: LLTClassification code 10010952Term: COPDCOPD
- Registration Number
- EUCTR2010-018668-18-GB
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
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
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 (e.g history of glaucoma) 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,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method