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.

NCT01727141 | Completed Phase 3 Results

• 1 other identifier: CQVA149A2336
• Study Type: interventional
• Target: 1,042
• Locations: 8 countries
• Sites: 143

Brief Summary

This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, QVA149

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))

  Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 \* visit interaction, and visit, treatment \* visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.

  baseline (BL), 12 Weeks

Secondary Outcomes (10)

• Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score

  BL, 12 Weeks

• Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score

  12 weeks

• Change From Baseline in Trough FEV1

  BL, day 2, day 86

• Change From Baseline in Pre-dose Trough FEV1

  BL, day 85

• Change From Baseline in FEV1

  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

Study Arms (4)

QVA149

EXPERIMENTAL

27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)

Drug: QVA149

QAB149

ACTIVE COMPARATOR

27.5 ug b.i.d.

Drug: QAB149

NVA237

ACTIVE COMPARATOR

12.5 ug b.i.d.

Drug: NVA237

Placebo

PLACEBO COMPARATOR

b.i.d

Drug: Placebo

Interventions

QVA149 DRUG

QVA149 was supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI

QVA149

QAB149 DRUG

QAB149 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.

QAB149

NVA237 DRUG

NVA237 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.

NVA237

Placebo DRUG

Placebo was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (143)

Novartis Investigative Site

Birmingham, Alabama, 35205, United States

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Montgomery, Alabama, 36109, United States

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Mesa, Arizona, 85205, United States

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Phoenix, Arizona, 85018, United States

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Fountain Valley, California, 92708, United States

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Fullerton, California, 92835, United States

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Huntington Beach, California, 92647, United States

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Montclair, California, 91763, United States

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Orange, California, 92868, United States

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Orangevale, California, 95662, United States

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Paramount, California, 90723, United States

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Riverside, California, 92506, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95817, United States

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Sacramento, California, 95823, United States

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Sacramento, California, 95825, United States

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San Diego, California, 92117-4946, United States

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Torrance, California, 90502, United States

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Wheat Ridge, Colorado, 80033, United States

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Waterbury, Connecticut, 06708, United States

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Chiefland, Florida, 32626, United States

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Clearwater, Florida, 33765, United States

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Lynn Haven, Florida, 32444, United States

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Savannah, Georgia, 31406, United States

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Meridian, Idaho, 83642, United States

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O'Fallon, Illinois, 62269, United States

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River Forest, Illinois, 60305, United States

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Indianapolis, Indiana, 46256, United States

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Columbia, Maryland, 21044, United States

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Waltham, Massachusetts, 02154, United States

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Ann Arbor, Michigan, 48106-0525, United States

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Edina, Minnesota, 55435, United States

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Fridley, Minnesota, 55432, United States

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Minneapolis, Minnesota, 55407, United States

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Rochester, Minnesota, 55901, United States

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Biloxi, Mississippi, 39531, United States

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Saint Charles, Missouri, 63301, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68134, United States

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Papillion, Nebraska, 68046, United States

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Las Vegas, Nevada, 89119, United States

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Brooklyn, New York, 11229, United States

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Brooklyn, New York, 11234, United States

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Great Neck, New York, 11021, United States

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Hendersonville, North Carolina, 28739, United States

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Cincinnati, Ohio, 45242, United States

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Cincinnati, Ohio, 45245, United States

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Columbus, Ohio, 43213, United States

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Columbus, Ohio, 43215, United States

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Dublin, Ohio, 43016, United States

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Marion, Ohio, 43302, United States

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Medford, Oregon, 97504-8741, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Pittsburgh, Pennsylvania, 15221, United States

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Pittsburgh, Pennsylvania, 15236, United States

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Pittsburgh, Pennsylvania, 15243, United States

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Tipton, Pennsylvania, 16684, United States

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Anderson, South Carolina, 29621, United States

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Greenville, South Carolina, 29615, United States

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Spartanburg, South Carolina, 29303, United States

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Union, South Carolina, 29379, United States

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Chattanooga, Tennessee, 37404, United States

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Boerne, Texas, 78006, United States

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Dallas, Texas, 75231-4307, United States

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Dallas, Texas, 75231, United States

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El Paso, Texas, 79902, United States

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San Antonio, Texas, 78205, United States

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South Burlington, Vermont, 05403, United States

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Newport News, Virginia, 23606, United States

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Richmond, Virginia, 23229, United States

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Richmond, Virginia, 23294, United States

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Seattle, Washington, United States

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Tacoma, Washington, 98405, United States

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Vancouver, British Columbia, V5Z 3J5, Canada

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Burlington, Ontario, L7N 3V2, Canada

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Courtice, Ontario, L1E 3C3, Canada

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Ottawa, Ontario, K1Y 4G2, Canada

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Toronto, Ontario, M5G1N8, Canada

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Toronto, Ontario, M5T 3A9, Canada

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Toronto, Ontario, M6H 3M2, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Gatineau, Quebec, J8Y 6S8, Canada

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Montreal, Quebec, H3G 1L5, Canada

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Pointe-Claire, Quebec, H9R 3j1, Canada

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Québec, Quebec, G1G 3Y8, Canada

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Québec, Quebec, G3K 2P8, Canada

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Québec, Quebec, GIV 4M6, Canada

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Saint Romuald, Quebec, G6W 5M6, Canada

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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

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Sainte-Foy, Quebec, G1V 4G5, Canada

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Sainte-Foy, Quebec, G1W 4R4, Canada

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Sherbrooke, Quebec, J1J 2G2, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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Victoriaville, Quebec, G6P 6P6, Canada

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Bulacan, Philippines, 3020, Philippines

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Manila, Philippines, 1000, Philippines

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Quezon City, 1100, Philippines

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San Pablo City, Laguna, 4000, Philippines

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Lodz, 90-153, Poland

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Tarnów, 33-100, Poland

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Wroclaw, 51-162, Poland

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Bucharest, District 1, 10457, Romania

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Bucharest, District 1, 11475, Romania

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Bucharest, District 3, 030303, Romania

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Bucharest, District 3, 030317, Romania

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Craiova, Dolj, 200515, Romania

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Iași, Jud. Iasi, 700115, Romania

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Arad, 310013, Romania

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Bucharest, 050159, Romania

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Deva, 330162, Romania

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Málaga, Andalusia, 29010, Spain

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Palma de Mallorca, Balearic Islands, 07120, Spain

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Santander, Cantabria, 39008, Spain

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Ponferrada, Castille and León, 24400, Spain

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Valladolid, Castille and León, 47011, Spain

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Barcelona, Catalonia, 08003, Spain

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Salt, Catalonia, 17190, Spain

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Sant Boi de Llobregat, Catalonia, 08830, Spain

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Cáceres, Extremadura, 10003, Spain

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Mérida, Extremadura, 06800, Spain

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Gijón, Principality of Asturias, 33290, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Dnipropetrovsk, Ukraine, 49074, Ukraine

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Kharkiv, Ukraine, 61039, Ukraine

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Kharkiv, Ukraine, 61124, Ukraine

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Dnipropetrovsk, 49027, Ukraine

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Donetsk, 83099, Ukraine

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Kharkiv, 61172, Ukraine

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Kiev, 02232, Ukraine

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Kiev, 04050, Ukraine

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Kyiv, 03680, Ukraine

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Kyiv, 04050, Ukraine

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Luhansk, 91055, Ukraine

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Lviv, Ukraine

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Poltava, 36024, Ukraine

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Vinnytsia, 21001, Ukraine

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Vinnytsia, 21018, Ukraine

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Zaporizhzhya, 69104, Ukraine

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Zaporizhzhya, 69600, Ukraine

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Zhytomyr, 10002, Ukraine

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Ho Chi Minh City, Vietnam, Vietnam

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Hanoi, Vietnam

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Ho Chi Minh City, Vietnam

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Related Publications (2)

• 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.

  PMID: 31539467 DERIVED

• 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.

  PMID: 26177074 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination; indacaterol; Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: November 15, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 29, 2016
• Results First Posted: June 9, 2015

Record last verified: 2016-03

Locations

VN (3); US (73); CA (21); PL (3); RO (9); PH (4); UA (18); ES (12)