Clinical trial NCT01727141: A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
Official title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, QVA149
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-11-15
Enrollment: 1042
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 assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.

Detailed description: NOTE: Detailed Description: data not entered

Eligibility criteria: Inclusion Criteria:

* Male and female patients that have signed informed consent and are \>/= 40 years of age.
* Patients with stable COPD according to GOLD 2011.
* Patients with a post-bronchodilator FEV1 of \>/= 30% and \< 80% predicted and a post-bronchodilator FEV1/FVC \<0.70.
* Current or ex-smokers who have a smoking history of at least 10 pack years.
* Patients with an mMRC grade 2 or greater.

Exclusion Criteria:

* Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (\>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)
* Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)
* Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
* Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
* Patients who had a COPD exacerbation within 6 weeks prior to screening.
* Patients who have a respiratory tract infection within 4 weeks prior to screening.
* Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
* Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
* Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
* Patients with concomitant pulmonary disease.
* Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
* Patients with active pulmonary tuberculosis.
* Patients in the active phase of a pulmonary rehabilitation programme.
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))
timeFrame: baseline (BL), 12 Weeks
Secondary outcomes:
measure: Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score
timeFrame: BL, 12 Weeks
measure: Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score
timeFrame: 12 weeks
measure: Change From Baseline in Trough FEV1
timeFrame: BL, day 2, day 86
measure: Change From Baseline in Pre-dose Trough FEV1
timeFrame: BL, day 85
measure: Change From Baseline in FEV1
timeFrame: BL, Day 1:5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55min;Day 86: 23h15min; 23h45min
measure: Change From Baseline in FVC
timeFrame: BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h 55min;Day 86: 23h15min; 23h45min
measure: Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)
timeFrame: BL, day 1, week 12
measure: Transitional Dyspnea Index (TDI) Focal Score
timeFrame: BL, 12 weeks
measure: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication
timeFrame: BL, 12 Weeks
measure: Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score
timeFrame: BL, 12 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Montgomery
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Mesa
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Fountain Valley
country: United States
facility: Novartis Investigative Site
state: California
city: Fullerton
country: United States
facility: Novartis Investigative Site
state: California
city: Huntington Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Montclair
country: United States
facility: Novartis Investigative Site
state: California
city: Orangevale
country: United States
facility: Novartis Investigative Site
state: California
city: Orange
country: United States
facility: Novartis Investigative Site
state: California
city: Paramount
country: United States
facility: Novartis Investigative Site
state: California
city: Riverside
country: United States
facility: Novartis Investigative Site
state: California
city: Roseville
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: Torrance
country: United States
facility: Novartis Investigative Site
state: California
city: Wheat Ridge
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Waterbury
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Chiefland
country: United States
facility: Novartis Investigative Site
state: Florida
city: Clearwater
country: United States
facility: Novartis Investigative Site
state: Florida
city: Lynn Haven
country: United States
facility: Novartis Investigative Site
state: Florida
city: Savannah
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Meridian
country: United States
facility: Novartis Investigative Site
state: Idaho
city: O'Fallon
country: United States
facility: Novartis Investigative Site
state: Illinois
city: River Forest
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Columbia
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Waltham
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Edina
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Fridley
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Rochester
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Biloxi
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: St. Charles
country: United States
facility: Novartis Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Papillion
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Brooklyn
country: United States
facility: Novartis Investigative Site
state: New York
city: Brooklyn
country: United States
facility: Novartis Investigative Site
state: New York
city: Great Neck
country: United States
facility: Novartis Investigative Site
state: New York
city: Hendersonville
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Dublin
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Marion
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Tipton
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Anderson
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Greenville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Union
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Chattanooga
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Boerne
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: El Paso
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: South Burlington
country: United States
facility: Novartis Investigative Site
state: Vermont
city: Newport News
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Burlington
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Courtice
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Windsor
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Gatineau
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Québec
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: St-Charles-Borromée
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: St-Romuald
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Trois-Rivières
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Victoriaville
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Quebec
country: Canada
facility: Novartis Investigative Site
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: Lodz
country: Poland
facility: Novartis Investigative Site
city: Tarnow
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 3
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 3
city: Craiova
country: Romania
facility: Novartis Investigative Site
state: Dolj
city: Iasi
country: Romania
facility: Novartis Investigative Site
state: Jud. Iasi
city: Arad
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Deva
country: Romania
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Gijon
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: Santander
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Ponferrada
country: Spain
facility: Novartis Investigative Site
state: Castilla y Leon
city: Valladolid
country: Spain
facility: Novartis Investigative Site
state: Castilla y Leon
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Salt
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Sant Boi de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Caceres
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: Mérida
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: Palma De Mallorca
country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
city: Baracaldo
country: Spain
facility: Novartis Investigative Site
state: Vizcaya
city: Dnipropetrovsk
country: Ukraine
facility: Novartis Investigative Site
city: Dnipropetrovsk
country: Ukraine
facility: Novartis Investigative Site
city: Donetsk
country: Ukraine
facility: Novartis Investigative Site
city: Kharkiv
country: Ukraine
facility: Novartis Investigative Site
city: Kharkiv
country: Ukraine
facility: Novartis Investigative Site
city: Kharkiv
country: Ukraine
facility: Novartis Investigative Site
city: Kiev
country: Ukraine
facility: Novartis Investigative Site
city: Kiev
country: Ukraine
facility: Novartis Investigative Site
city: Kyiv
country: Ukraine
facility: Novartis Investigative Site
city: Kyiv
country: Ukraine
facility: Novartis Investigative Site
city: Luhansk
country: Ukraine
facility: Novartis Investigative Site
city: Lviv
country: Ukraine
facility: Novartis Investigative Site
city: Poltava
country: Ukraine
facility: Novartis Investigative Site
city: Vinnytsia
country: Ukraine
facility: Novartis Investigative Site
city: Vinnytsia
country: Ukraine
facility: Novartis Investigative Site
city: Zaporizhzhya
country: Ukraine
facility: Novartis Investigative Site
city: Zaporizhzhya
country: Ukraine
facility: Novartis Investigative Site
city: Zhytomyr
country: Ukraine
facility: Novartis Investigative Site
city: Hanoi
country: Vietnam
facility: Novartis Investigative Site
city: Ho Chi Minh City
country: Vietnam
facility: Novartis Investigative Site
city: Ho Chi Minh
country: Vietnam
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Mahler DA, Kerwin E, Murray L, Dembek C. The Impact of Twice-Daily Indacaterol/Glycopyrrolate on the Components of Health-Related Quality of Life and Dyspnea in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4):308-20. doi: 10.15326/jcopdf.6.4.2019.0131.
citation: Mahler DA, Kerwin E, Ayers T, FowlerTaylor A, Maitra S, Thach C, Lloyd M, Patalano F, Banerji D. FLIGHT1 and FLIGHT2: Efficacy and Safety of QVA149 (Indacaterol/Glycopyrrolate) versus Its Monocomponents and Placebo in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1068-79. doi: 10.1164/rccm.201505-1048OC.