Study to assess the effect of glycopyrronium versus tiotropium on morning symptoms and pulmonary function in patients with moderate to severe COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 16.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-002483-84-ES
- Lead Sponsor
- ovartis Farmacéutica, S. A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1. Patients who have signed an Informed Consent Form before any assessment is performed.
2. Male and female adults aged ? 40 years.
3. Co-operative outpatients with a clinical diagnosis of moderate to severe COPD confirmed by spirometry according to GOLD criteria 2013 and including all of the following:
a. Current or ex-smokers who have a smoking history of at least 10 pack years (e.g.10 pack years = 1 pack /day x 10 years or ½ pack/day x 20 years). An ex-smoker may be defined as a subject who has not smoked for ? 6 months at Screening.
b. Patients with airflow limitation indicated by a post-bronchodilator FEV1 < 80% and ? 40% of the predicted normal value at Visit 2 (Post- bronchodilator refers to within 10-
15 min of inhalation of 400 ?g (4x100 ?g) of salbutamol).
c. Post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (Post- bronchodilator refers to within 10-15 min of inhalation of 400 ?g (4x100 ?g) of salbutamol).
4. Patients with a COPD Assessment Test (CAT) score ? 10 at Visit 2.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
1. Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to Visit 1. In the event of an exacerbation occurring during the Screening period (Visits 1-2), the patient must be discontinued from the study.
2. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection between Visit 1 and Visit 2 must discontinue from the trial, but may be permitted to re-enrol at a later date once the inclusion/exclusion criteria have been met.
3. Patients on any long-acting bronchodilator therapy. Those patients may enter the study after bronchodilator withdrawal during a 10-day wash-out period (only rescue salbutamol
allowed as bronchodilator therapy during wash-out). Patients on fixed combination of long acting ?2-agonists/inhaled corticosteroid (LABA/ICS) therapy before screening must be switched to the equivalent dose of ICS monotherapy and salbutamol as rescue.
4. Patients receiving any other prohibited COPD-related medications specified in Table 5-1 must undergo the required wash-out period prior to Visit 2.
5. Patients who have had a clinical history of asthma.
6. Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis or clinically significant bronchiectasis.
7. Patients with alpha-1-antitrypsin deficiency.
8. Patients with contraindications for LAMA treatment including medical history of symptomatic prostatic hypertrophy, bladder neck obstruction, narrow-angle glaucoma and severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2) documented in the previous 6 months.
9. Patients with a history of unstable cardiovascular disease or arrhythmias including atrial fibrillation/flutter or long QT syndrome or whose resting QTcF (calculated according to Fridericia QT correction formula preferred, but Bazett acceptable) is prolonged (? 450 msec for males and ? 460 msec for females) at screening (Visit 1) or baseline (Visit 2, baseline 1).
10. Concomitant use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study.
11. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof:
? anticholinergic agents
? long and short acting ?2-agonists
? sympathomimetic amines
? excipients of the trial medication (lactose monohydrate and/or magnesium estearate)
12. Patients whose body mass index (BMI) is less than 15 or greater than 40 kg/m2.
13. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
14. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hCG) laboratory test (> 5 mIU/mL).
15. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods include:
? Total abstinence
? Female sterilization
? Male sterilization
? Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical
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