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

COPD Clinical Trial

— FLASH  

Official title:

A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Switching From Salmeterol/Fluticasone to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516592
• Other study ID #: CQVA149A3405
• Status: Completed
• Phase: Phase 4
• Start date: October 13, 2015
• Est. completion date: May 4, 2017

Study information

• Verified date: December 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 4, 2017
• Est. primary completion date: May 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• QVA149 110/50 micrograms
QVA149 110/50 micrograms o.d. capsules for inhalation, supplied in blisters via a single dose dry powder inhalater (SDDPI)
• Salmeterol/fluticasone 50/500 microgrammes
Salmeterol/fluticasone 50/500 microgrammes b.i.d.dry inhalation powder delivered via Accuhaler / Diskus device

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Bedford Park	South Australia
Australia	Novartis Investigative Site	Cairns	Queensland
Australia	Novartis Investigative Site	Coffs Harbour	New South Wales
Australia	Novartis Investigative Site	Daw Park	South Austrailia
Australia	Novartis Investigative Site	Drummoyne	New South Wales
Australia	Novartis Investigative Site	Glen Osmond	South Australia
Australia	Novartis Investigative Site	Murdoch	Western Australia
Australia	Novartis Investigative Site	Westmead	New South Wales
Egypt	Novartis Investigative Site	Alexandria
Egypt	Novartis Investigative Site	Cairo
Egypt	Novartis Investigative Site	Fayoum
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Coimbatore	Tamil Nadu
India	Novartis Investigative Site	Mohali	Punjab
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	New Delhi
Israel	Novartis Investigative Site	Ashkelon
Israel	Novartis Investigative Site	Be'er Sheva
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Rehovot
Israel	Novartis Investigative Site	Sefad
Israel	Novartis Investigative Site	Tel Giborim, Holon
Lebanon	Novartis Investigative Site	Ashrafieh
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	El Chouf	LBN
Lebanon	Novartis Investigative Site	Hazmieh
Lebanon	Novartis Investigative Site	Saida
Malaysia	Novartis Investigative Site	Kota Bharu	Kelantan
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Kuantan	Pahang
Malaysia	Novartis Investigative Site	Kuching	Sarawak
Malaysia	Novartis Investigative Site	Miri	Sarawak
Malaysia	Novartis Investigative Site	Taiping	Perak
Philippines	Novartis Investigative Site	Bulacan
Philippines	Novartis Investigative Site	Lipa City	Batangas
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Quezon City
Philippines	Novartis Investigative Site	San Pablo City, Laguna
Saudi Arabia	Novartis Investigative Site	Jeddah
Saudi Arabia	Novartis Investigative Site	Riyadh	SAU
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Durban
South Africa	Novartis Investigative Site	Gatesville
South Africa	Novartis Investigative Site	Johannesburg
South Africa	Novartis Investigative Site	Phoenix
Taiwan	Novartis Investigative Site	Kaoshiung
Taiwan	Novartis Investigative Site	Lin-Kou
Taiwan	Novartis Investigative Site	New Taipei
Taiwan	Novartis Investigative Site	Taichung
Turkey	Novartis Investigative Site	Adana
Turkey	Novartis Investigative Site	Aydin
Turkey	Novartis Investigative Site	Erzurum
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Konya
Turkey	Novartis Investigative Site	Mersin
Turkey	Novartis Investigative Site	Trabzon
Turkey	Novartis Investigative Site	Yenisehir/Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Egypt,  India,  Israel,  Lebanon,  Malaysia,  Philippines,  Saudi Arabia,  South Africa,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Trough Pre-dose FEV1 in Both Arms	Pulmonary function assessments were performed using centralized spirometry according to international standards. Mean trough pre-dose FEV1 at Week 12 is defined as the average of the measurements taken -45min and -15min pre study medication dose in the clinic after 12 weeks of treatment (Day 84). The baseline measurement is defined as the average of the scheduled FEV1 values prior to first intake of randomized study drug at Day 1 (Visit 2).	Baseline, week 12
Secondary	Transitional Dyspnea Index (TDI) Focal Score	Transition Dyspnea Index (TDI) is an instrument used to assess a participant's level of dyspnea. The TDI focal score have three domains: functional impairment, magnitude of task and magnitude of effort. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of =1 was defined as a clinically important improvement from baseline.	Baseline, week 12
Secondary	Change From Baseline in FVC (Forced Vital Capacity)	Pulmonary function assessments were performed using centralized spirometry according to international standards. FVC wil follow the same analysis as for FEV1	week 12
Secondary	Change From Baseline in Total Symptom Score- CAT (COPD Assessment Test)	The participants will record their COPD symptoms in this test before every clinic visit, this will include : cough, phlegm, chest tightness, breathlessness, limitation in activities, energy, soundly sleep, etc. A higher score indicates a worse health status. The result is immediately available without the need for any calculation, apart from summing the scores on individual items. Scores of 0 - 10 represent mild, 11 - 20 represent moderate, 21 - 30 represent severe and 31 - 40 represent very severe clinical impact of COPD upon the patient.	week 12
Secondary	Change From Baseline in Mean Daily Use of Rescue Medication	Use of rescue medication (number of puffs taken in the previous 12 hours) is recorded morning and evening, by the patient, in a paper diary. A negative change from baseline indicates an improvement.	over 12 weeks