chronic obstructive pulmonary disease (COPD) MedDRA version: 16.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Ultibro Breezhaler 85 microgramms/43 microgramms, inhalation powder hard capsule
Product Name: Ultibro Breezhaler 85 microgramms/43 microgramms, inhalation powder hard capsule
Product Code
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adults aged =40 years. 2. Patients who have signed an Informed Consent Form prior to initiation of any study-related procedure. 3. Patients with stable COPD according to current guidelines (GOLD 2013). 4. Patients with airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of =65 years) yes F.1.3.1 Number of subjects for this age range 68
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast feeding mothers (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5mIU/ml)). 2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use effective contraception (Pearl Index 40 mIU/m OR 6 weeks after surgical bilateral oophorectomy (with or without hysterectomy). 3. Patients with conditions 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 beta-2 agonists • sympathomimetic amines • lactose or any of the other excipients 4. Patients with a history of clinically significant diseases that, in the opinion of the investigator, would put the safety of the patients at risk through study participation, or would compromise patient compliance or preclude completion of the study. 5. Patients who have a clinically significant renal disease (moderate to severe renal impairment GFR 12 h a day) on a daily basis for chronic hypoxia. 19. Patients who have had a COPD exacerbation that required treatment with antibiotics, and/or systemic steroids and/or hospitalization in the 6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of QVA149 (100/50 µg o.d.) as compared to tiotropium (18 µg o.d.) in terms of FEV1 1 h post-inhalation after 4 weeks of treatment in patients with stable COPD and moderate to severe airflow limitation still having symptoms (CAT score of at least 10) despite treatment with tiotropium.;Secondary Objective: • To evaluate patient preference for a QVA149 or tiotropium treatment after experiencing both treatment regimens • To evaluate investigator preference for the future treatment suggestion of the patient after experiencing both treatment regimens • To evaluate safety parameters of both treatment regimens ;Primary end point(s): Demonstration of superiority of QVA149 (100/50 µg o.d.) as compared to tiotropium (18 µg o.d.) in terms of FEV1 1 h post-inhalation after 4 weeks of treatment in patients with stable COPD and moderate to severe airflow limitation still having symptoms despite treatment with tiotropium.;Timepoint(s) of evaluation of this end point: after 4 and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of patient preference for a QVA149 or tiotropium treatment after experiencing both treatment regimens. Evaluation of investigator preference for the future treatment suggestion of the patient after experiencing both treatment regimens. Evaluation of safety parameters of both treatment regimens. ;Timepoint(s) of evaluation of this end point: after 4 and 8 weeks | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed