Phase 2b COPD Study / A6631033
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 15.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-005864-11-PL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 660
Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Male or female subjects between, and including, the ages of 40 and 80 years.
2. Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease:
• Subjects must have a post-bronchodilator FEV1/FVC ratio <0.7 and a post- bronchodilator FEV1 of 30 - 80% (inclusive) of the predicted value for age, height, race and sex using European Community for Coal and Steel ECCS standards or NHANES III standards. To qualify for randomization, these criteria must be met at Screening and replicated during run-in phase (see Randomization Criteria for details).
3. Subjects must have a smoking history of at least 10 pack-years* and meet one of the following criteria:
• They are current smokers, or
• They are ex-smokers who have abstained from smoking for at least 6 months.
*Formula for pack-years: cigarettes = (average number of cigarettes/day ÷ 20) x years of smoking, tobacco = ounces per week x 2/7 x years of smoking.
4. Subjects treated with tiotropium bromide (SPIRIVA® HandiHaler®) 18 µg daily for at least 1 month prior to screening.
5. Subjects must have had stable disease for at least 1 month prior to screening. During the screening and run-in phase subjects must be able to manage disease symptoms adequately with tiotropium bromide ±salbutamol (albuterol) rescue medication (subjects should not use >10 actuations [100 µg/actuations] daily for more than 2 consecutive days), without reliance on other therapies including oral or inhaled corticosteroids, other long-acting bronchodilators, nebulizer therapy, theophylline, roflumilast or regular oxygen.
6. Body Mass Index (BMI) <35 kg/m2 and a total body weight >40 kg.
7. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal acceptable representative) has been informed of all pertinent aspects of the study).Subjects must be able to give informed, written consent prior to entering the study.
8. Subjects who are willing and able to comply with schedules visits, treatment plan, laboratory tests, and other study procedures.Subjects must be willing and able to comply with scheduled visit and all study-related procedures.
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 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 330
Subjects presenting with any of the following will not be included in the study:
1. A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening.
2. History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomization.
3. History or presence of respiratory failure, cor pulmonale or right ventricular failure.
4. Subjects with home oxygen therapy (either PRN or long-term oxygen therapy).
5. Any clearly documented history of adult asthma or other chronic respiratory disorders (eg, bronchiectasis, pulmonary fibrosis, pneumoconiosis).
6. Known previous diagnosis of Hepatitis B or C or HIV infection (specific screening is not required).
7. History of cancer (other than cutaneous basal cell) in the previous 5 years.
8. Active or past history of GI hemorrhage of any etiology, peptic ulceration, erosive esophagitis, gastric outlet obstruction or inflammatory bowel disease.
9. Regular use of aspirin at a dose greater than 325 mg/day.
10. History within the previous 6 months of: myocardial infarction, cardiac arrhythmia (eg, atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
11. A family history of long QT syndrome.
12. Tuberculosis (TB): In order to be enrolled in the study, subjects will be screened for TB. Presence of any of the following means that the subject will be excluded:
• Evidence or history of either untreated or inadequately treated latent or active tuberculosis infection.
• A subject who is currently being treated for active TB infection. Note: a subject currently being treated for latent TB infection may be enrolled if criteria described in the protocol are met.
• Positive reaction (=5 mm induration) of the PPD tuberculin skin test unless there has been documented vaccination with the bacilli Calmette-Guerin vaccine (BCG).
• Chest X-ray (within last 3 months) with changes suggestive of active TB infection as determined by a qualified radiologist.
13. History within the previous 6 months of:
• An epileptic seizure.
• Poorly controlled Type 1 or Type 2 diabetes.
• Acute hepatitis of any aetiology.
14. Presenting with:
• Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
• Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0
• Any clinically significant active systemic or cutaneous infection including herpetic lesions.
• Congestive heart failure requiring treatment New York Heart Association (NYHA) Class III-IV.
15. A major surgical operation within 1 month of screening.
16. ECG abnormalities at screening or randomization, including those listed below. The investigator will decide whether ECG abnormalities other than those listed are clinically significant and should exclude the subject from enrolment if abnormality is considered to be clinically significant:
• Subjects with pre-randomization evidence of QTcF prolongation (defined as
>450 ms) at screening or baseline (Week 0) are not eligible for randomization. This assessment is based on a confirmed me
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