Assessment of the early bronchodilation of Glycopyrronium bromide compared to Tiotropium in patients with moderate to severe COPD
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 16.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-001445-13-DE
- Lead Sponsor
- ovartis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 152
1.Male or female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
2.Patients with moderate to severe COPD defined by a post-bronchodilator FEV1/FVC ratio of <0.70 and a post-bronchodilator FEV1 of =70% and FEV1 = 30% of predicted normal values.
3.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 etc.)
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
o History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
o History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
o Patients, who have already been randomized into this trial earlier must not be included a second time.
o Study personnel or first degree relatives of investigator(s) must not be included in the study.
o Patients incapable of giving full informed consent.
Women
o who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml))
o who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (Pearl Index <1) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women is required with sufficient lead time before inclusion
COPD specific exclusion criteria
1.Patients with Type I or uncontrolled Type II diabetes (HbA1C > 8%).
2.Patients with a history of long QT syndrome or whose QTc calculated at run-in (Bazett formula) is prolonged (>450 ms). These patients should not be re-enrolled.
3.Patients who have a clinically significant ECG abnormality at run-in.
4.Patients who have a clinically significant laboratory abnormality at run-in.
5.Patients with a body mass index (BMI) of more than 40 kg/m2.
6.Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or haemotological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment.
7.Patients with paroxysmal (e.g., intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blockers, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at the run-in (Visit 2) with a resting ventricular rate < 100/min.
8.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:
a.Muscarinic antagonist agents
b.long and short acting beta-2 agonists
c.sympathomimetic amines
d.lactose or any of the other excipients of the trial medication
9.Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR <50 ml/min/1,732) or urinary retention. (BPH patients who are stable on treatment can be considered).
10.Patients who have not achieved acceptable spirometry results at run-in in accordance with ATS/ERS criteria for acceptability and repeatability.
11.Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening.
12.Patients who develop a COPD exacerba
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