Study to evaluate the efficacy and safety of glycopyrronium or indacaterol maleate and glycopyrronium bromide fixed - dose combination regarding symptoms and health status in patients with moderate COPD switching from treatment with any standard COPD regime
- Conditions
- Chronic obstructive pulmonary disease (COPD)MedDRA version: 18.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-003127-11-SI
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4470
1. Patients who have signed an Informed Consent Form before any
assessment is performed.
2. Male and female adults aged = 40 years.
3. Patients with moderate COPD according to the GOLD criteria 2013.
4. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years. An ex-smoker is defined as a subject who has not smoked for = 6 months at Visit 1.)
5. Patients with airflow limitation indicated by a post-bronchodilator FEV1 =50% and <80% of the predicted normal value and a post-bronchodilator FEV1/FVC <0.7 at Visit 2. Post-bronchodilator refers to within 10-15 min of inhalation of 400 µg (4x100 µg) of salbutamol.
6. Patients who, at Visit 1, have been for at least 3 months on a stable dose of one of the following COPD baseline treatments:
- Any SABA monotherapy (such as, but not limited to, salbutamol),
- Any SAMA monotherapy (such as, but not limited to, ipratropium),
- Any SABA and SAMA in free or FDC (such as, but not limited to, salbutamol/ipratropium),
- Any LABA monotherapy (such as, but not limited to, formoterol, salmeterol, indacaterol),
- Any LAMA monotherapy (such as, but not limited to, tiotropium, aclidinium) except glycopyrronium bromide (NVA237),
- Any LABA and ICS in free (ICS such as, but not limited to, beclomethasone, fluticasone) or FDC (such as, but not limited to, salmeterol/fluticasone, formoterol/budesonide)
The exact list of therapies (either active ingredients or FDC) will depend on the available therapies on the market in the participating countries.
7. Patients with an mMRC score =1 at Visit 1.
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 1341
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3129
1. Patients with conditions contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs or to drugs of similar chemical classes or any component thereof:
• Anti-cholinergic agents
• Long- and short-acting ß2-adrenergic agonists
• Sympathomimetic amines
• Lactose or any of the other excipients of the trial medication.
2. Patients with narrow-angle glaucoma or urinary retention, severe renal impairment (history of estimated glomerular filtration rate below 30 ml/min/1.73 m2 within 12 months prior to visit 1), including those with end-stage renal disease requiring dialysis.
3. Patients with active/ clinical history of asthma. If the Investigator finds clear and compelling evidence that a patient was misdiagnosed with asthma in the past, then the burden of proof is on the Investigator to properly document this previous misdiagnosis. This documentation must include the rationale for this change in diagnosis including reference to the differential diagnosis that supports this decision.
4. Patients with a 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.
5. Patients who have a post-bronchodilator FEV1 decrease more than 10% compared to pre-bronchodilator FEV1 at Visit 2.
6. A documented history of >1 COPD exacerbation requiring treatment with systemic corticosteroids or antibiotics and/or hospitalization in the previous 12 months. Patients who have NOT had a COPD exacerbation in the previous 12 months and develop a COPD exacerbation between screening (Visit 1) and baseline (Visit 2) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation. (Patients suffering an exacerbation between Visit 1 and Visit 2 can only be re-screened in case it is the first one in the previous 12 months). In case this COPD exacerbation has led to an alteration of the patient COPD treatment, before this patient can be re-screened 3 months of stable COPD treatment will be required as described in Inclusion Criterion 6).
7. Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to):
• Unstable ischemic heart disease, left ventricular failure (NYHA Class III & IV), history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation). Patients with such events not considered clinically significant by the investigator may be considered for inclusion in the study
• Uncontrolled hypo-or hyperthyroidism, hypokalaemia or hyperadrenergic state
• Any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
8. History of resting QTc (Fridericia preferred, but Bazett acceptable) >450 msec (male) or >460 msec (female) within five years before Visit 1.
9. Patients who are treated with glycopyrronium bromide (NVA237) at visit 1 are not allowed to be included into the trial. Patients on non-selective beta-blockers. Those patients may enter the study after non-selective beta-blocker withdrawal during a 7-day washout period.
10. Patients receiving any other prohibited COPD-related medications specified in Table 5-2 Prohibited COPD-related medications must undergo
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