Clinical trial NCT02516592: Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-08-06
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Trough Pre-dose FEV1 in Both Arms
timeFrame: Baseline, week 12
Secondary outcomes:
measure: Transitional Dyspnea Index (TDI) Focal Score
timeFrame: Baseline, week 12
measure: Change From Baseline in FVC (Forced Vital Capacity)
timeFrame: week 12
measure: Change From Baseline in Total Symptom Score- CAT (COPD Assessment Test)
timeFrame: week 12
measure: Change From Baseline in Mean Daily Use of Rescue Medication
timeFrame: over 12 weeks
Other outcomes:
Locations:
city: Coffs Harbour
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Drummoyne
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Westmead
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Cairns
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Daw Park
country: Australia
facility: Novartis Investigative Site
state: South Austrailia
city: Bedford Park
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Glen Osmond
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Murdoch
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Alexandria
country: Egypt
facility: Novartis Investigative Site
city: Cairo
country: Egypt
facility: Novartis Investigative Site
city: Fayoum
country: Egypt
facility: Novartis Investigative Site
city: Ahmedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Mohali
country: India
facility: Novartis Investigative Site
state: Punjab
city: Coimbatore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: New Delhi
country: India
facility: Novartis Investigative Site
city: Ashkelon
country: Israel
facility: Novartis Investigative Site
city: Be'er Sheva
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Sefad
country: Israel
facility: Novartis Investigative Site
city: Tel Giborim, Holon
country: Israel
facility: Novartis Investigative Site
city: El Chouf
country: Lebanon
facility: Novartis Investigative Site
state: LBN
city: Ashrafieh
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Hazmieh
country: Lebanon
facility: Novartis Investigative Site
city: Saida
country: Lebanon
facility: Novartis Investigative Site
city: Kota Bharu
country: Malaysia
facility: Novartis Investigative Site
state: Kelantan
city: Kuantan
country: Malaysia
facility: Novartis Investigative Site
state: Pahang
city: Taiping
country: Malaysia
facility: Novartis Investigative Site
state: Perak
city: Kuching
country: Malaysia
facility: Novartis Investigative Site
state: Sarawak
city: Miri
country: Malaysia
facility: Novartis Investigative Site
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Lipa City
country: Philippines
facility: Novartis Investigative Site
state: Batangas
city: Bulacan
country: Philippines
facility: Novartis Investigative Site
city: Manila
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: San Pablo City, Laguna
country: Philippines
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
state: SAU
city: Jeddah
country: Saudi Arabia
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Durban
country: South Africa
facility: Novartis Investigative Site
city: Gatesville
country: South Africa
facility: Novartis Investigative Site
city: Johannesburg
country: South Africa
facility: Novartis Investigative Site
city: Phoenix
country: South Africa
facility: Novartis Investigative Site
city: Kaoshiung
country: Taiwan
facility: Novartis Investigative Site
city: Lin-Kou
country: Taiwan
facility: Novartis Investigative Site
city: New Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Adana
country: Turkey
facility: Novartis Investigative Site
city: Aydin
country: Turkey
facility: Novartis Investigative Site
city: Erzurum
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Konya
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Trabzon
country: Turkey
facility: Novartis Investigative Site
city: Yenisehir/Izmir
country: Turkey
facility: Novartis Investigative Site
Study officials:
References:
citation: Frith PA, Ashmawi S, Krishnamurthy S, Gurgun A, Hristoskova S, Pilipovic V, Hamann AM, Backer A, Olsson P, Kostikas K, Diaz DV; FLASH Investigators. Efficacy and safety of the direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in non-frequently exacerbating COPD patients: The FLASH randomized controlled trial. Respirology. 2018 Dec;23(12):1152-1159. doi: 10.1111/resp.13374. Epub 2018 Aug 3.