Evaluation of the efficacy and safety of QVA149 (110/50 ?g o.d.) vs tiotropium (18 ?g o.d.) + salmeterol/fluticasone propionate FDC (50/500 ?g b.i.d.) in patients with moderate to severe COPD

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 18.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-000114-22-ES
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-30
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

- Patients who have signed Informed Consent Form prior to initiation of any study-related procedure.
- Male and female adults aged ? 40 years.
- Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3)according to the 2014 GOLD Guidelines.
- Patients with a post-bronchodilator FEV1?40 and < 80% of the predicted normal value, and post-bronchodilator FEV1/FVC <0.70 at run-in Visit 101. (Post refers to 15 min after inhalation of 400 ?g of salbutamol).
- 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 is defined as a patient who has not smoked for ? 6 months at screening.
- Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 700

Exclusion Criteria

- Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don?t meet the acceptability
criteria)
- Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1.
- Patients who developed a COPD exacerbation of any severity either 6 weeks before the
screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified