Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort (FLASH)

Novartis

Status and phase: Completed; Phase 4

Conditions: COPD

Treatments: Drug: QVA149 110/50 micrograms; Drug: Salmeterol/fluticasone 50/500 microgrammes

Study type: Interventional

Funder types: Industry

Identifiers

NCT02516592

CQVA149A3405

Details and patient eligibility

About

This study will investigate whether switching symptomatic COPD patients from a fixed-dose combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149 110/50 µg o.d. leads to improved lung function and airflow. It will also assess the effect on symptom burden, breathlessness, and use of rescue medication after this switch.

Enrollment: 500 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent must be obtained before any assessment is performed.
• Male and female ≥ 40 years
• Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack years are defined as 20 cigarettes per day for 10 years or 10 cigarettes per day for 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at visit 1
• Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted normal value and post-bronchodilator FEV1/FVC < 0.70 at visit 1
• Treated with salmeterol/fluticasone 50/500 µg b.i.d. for at least 3 months prior to visit 1
• Documented CAT score of ≥ 10 at Visit 1 and 2

Exclusion criteria

• Treatment with any LAMA in the 2 weeks prior to visit 1
• Presence of any contraindication, warning, precaution, hypersensitivity in the approved prescribing information for salmeterol/fluticasone
• Prior or current diagnosis of asthma
• More than one COPD exacerbation requiring treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the year prior to Visit 1
• Patients who developed a COPD exacerbation of any severity within the 6 weeks before the screening (Visit 1) or between screening (Visit 1) and start of treatment (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
• Respiratory tract infection within 4 weeks prior to Visit 1
• Respiratory tract infection between Visit 1 and 2. Patients can be re-screened 4 weeks after resolution of the infection
• Requiring oxygen therapy prescribed for >12 hours per day
• Onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

500 participants in 2 patient groups

QVA149 110/50 micrograms

Experimental group

Description:

QVA149 110/50 micrograms o.d. Capsules for inhalation

Treatment:

Drug: QVA149 110/50 micrograms

salmeterol/fluticasone 50/500 micrograms

Active Comparator group

Description:

salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder

Treatment:

Drug: Salmeterol/fluticasone 50/500 microgrammes