Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 17.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Sponsors
Novartis Sverige AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Male or female adults aged =40 years 3. Resting daytime oxygen saturation levels measured by pulse oximetry of =95% Sa02 4. Patients with a post-bronchodilator FEV1 =30% and =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Patients fulfilling any of the following criteria are not eligible for inclusion in this study. 1. Women of childbearing potential not using contraception method(s), as well as women who are breastfeeding 2. Ongoing / planned rehabilitation during the study period 3. An exacerbation of COPD (treatment with oral or parenteral antibiotics and/or glucocorticosteroids and/or hospitalization related to COPD) within 4 weeks prior to screening or during the run-in period 4. Use of oral or systemic glucocorticosteroids within 4 weeks prior to screening or during the run-in period 5. 3 or more awakenings during the night leading to toilet visit or other reasons for exiting the bed during the last week prior to the screening visit due to non-COPD reasons (morning toilet visit not included) 6. Respiratory tract infection in the 4 weeks prior to screening or during the run-in period 7. Body Mass Index (BMI) >32 8. Diagnosed asthma 9. Malignancy of any organ system (except localized basal cell carcinoma of the skin) 10. Diabetes mellitus requiring insulin 11. Long QT syndrome or QTc>450 ms (males) or 470 ms (females) 12. Severe renal impairment (GFR: =30 ml/min/1.73 m2) 13. Patients receiving regular long term oxygen therapy (LTOT) 14. Known sleep apnea (=15 apneas or hypopneas per hour of sleep) or who have or have had previous Bilevel Positive Airway Pressure (BIPAP) or Continuous Positive Airway Pressure (CPAP) therapy for sleep apnea 15. Symptomatic urinary outflow obstruction 16. Shift workers (or other external conditions affecting sleep and sleep quality on a regular basis) 17. Narrow-angle glaucoma 18. Hypersensitivity to any of the ingredients 19. Unstable (based upon the investigator evaluation) cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the level of improvement in mean night time Sa02 following 4 week's administration of QVA149 compared to placebo.;Secondary Objective: Secondary objective - To assess the time spent below 90% in SaO2 following 4 week`s administration of QVA149 compared to placebo Explorative objectives: -To assess lung function and lung volumes following 4 week's administration of QVA149 compared to placebo measured in the morning prior to drug administration. Will be performed at selected sites. -To assess the effect of QVA149 versus placebo on sleep quality: Medical Outcomes Study Scale-Sleep (MOS-sleep) and COPD and Asthma Sleep Impact Scale (CASIS) questionnaires. -To assess the effect of QVA149 versus placebo on the level of COPD symptoms assessed by COPD assessment test (CAT) questionnaire.;Primary end point(s): Mean night-time oxygen hemoglobin saturation level;Timepoint(s) of evaluation of this end point: Timeframe: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Lung function and lung volumes measured in the morning prior to drug administration -Sleep quality (Medical Outcomes Study Scale-Sleep (MOS-sleep) and COPD and Asthma Sleep Impact Scale (CASIS) questionnaires) -Level of COPD symptoms assessed by COPD assessment test (CAT) questionnaire ;Timepoint(s) of evaluation of this end point: Timeframe: 28 days | — |
Countries
Denmark, Sweden
Contacts
Public ContactMedicinsk Information
Novartis Healthcare A/S
Outcome results
None listed