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

NCT01712516 | Completed Phase 3 Results

• 1 other identifier: CQVA149A2337
• Study Type: interventional
• Target: 1,001
• Locations: 8 countries
• Sites: 94

Brief Summary

This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, QVA149

Outcome Measures

Primary Outcomes (1)

• Primary: 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, 11h; day 86: 23h15min; 23h45min

Study Arms (4)

QVA149

EXPERIMENTAL

27.5/12.5 ug twice daily (b.i.d.) 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 (95)

Novartis Investigative Site

Huntsville, Alabama, 35801, United States

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Novartis Investigative Site

*See Various Dept.'s*, Arizona, United States

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Tempe, Arizona, 85283, United States

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Buena Park, California, 90620, United States

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Fullerton, California, 92835, United States

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Palmdale, California, 93551, United States

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Riverside, California, 92506, United States

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San Diego, California, 92120, United States

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Sepulveda, California, 91343, United States

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Clearwater, Florida, 33756, United States

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Clearwater, Florida, 33765, United States

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DeLand, Florida, 32720, United States

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Fort Lauderdale, Florida, 33316-192, United States

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Miami, Florida, 33156, United States

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Miami, Florida, 33186, United States

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Orlando, Florida, 32806, United States

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Pensacola, Florida, 32503, United States

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Pensacola, Florida, 32504, United States

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Port Orange, Florida, 32127, United States

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Sarasota, Florida, 34233, United States

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Tamarac, Florida, 33321, United States

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Tampa, Florida, 33603, United States

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Winter Park, Florida, 32789, United States

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Lawrenceville, Georgia, 30046, United States

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Opelousas, Louisiana, 70570, United States

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Henderson, Nevada, 89014, United States

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Las Vegas, Nevada, 89119, United States

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Reno, Nevada, 89520, United States

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Brandon, New Jersey, 33511, United States

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Charlotte, North Carolina, 28207, United States

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Huntersville, North Carolina, 28078, United States

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Raleigh, North Carolina, 27607, United States

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Shelby, North Carolina, 28150, United States

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Shelby, North Carolina, 28152, United States

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Charleston, South Carolina, 29406-7108, United States

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Charleston, South Carolina, 29412, United States

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Columbia, South Carolina, 29201, United States

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Easley, South Carolina, 29640, United States

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Gaffney, South Carolina, 29340, United States

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Greenville, South Carolina, 29615, United States

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Pelzer, South Carolina, 29669, United States

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Rock Hll, South Carolina, 29732, United States

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Seneca, South Carolina, 29678, United States

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Simpsonville, South Carolina, 29681, 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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Johnson City, Tennessee, 37601, United States

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Arlington, Texas, 76012, United States

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Corsicana, Texas, 75110, United States

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Dallas, Texas, 75216, United States

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Dallas, Texas, 75235, United States

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Fort Worth, Texas, 76104, United States

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Fort Worth, Texas, 76107, United States

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Lufkin, Texas, 75904, United States

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McKinney, Texas, 75069, United States

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Tyler, Texas, 75708, United States

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Barranquilla, Atlántico, Colombia

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Armenia, Colombia

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Barranquilla, Colombia

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Alexandria, 21131, Egypt

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Beuvry, France, 62660, France

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Nantes, 44000, France

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Paris, 75013, France

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Reims, 51092, France

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Guatemala City, Departamento de Guatemala, 01010, Guatemala

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Guatemala City, Departamento de Guatemala, 01011, Guatemala

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Guatemala City, Departamento de Guatemala, 01015, Guatemala

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Balassagyarmat, Hungary, 2660, Hungary

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Debrecen, Hungary, 4032, Hungary

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Komárom, Hungary, 2900, Hungary

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Tatabánya, Hungary, 2800, Hungary

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Deszk, 6772, Hungary

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Gödöllő, 2100, Hungary

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Győr, 9024, Hungary

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Novartis Investigative Site

Makó, 6900, Hungary

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Miskolc, 3529, Hungary

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Százhalombatta, 2440, Hungary

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Szombathely, 9700, Hungary

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Novartis Investigative Site

Panama City, Provincia de Panamá, Panama

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Bardejov, Slovak Republic, 085 01, Slovakia

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Novartis Investigative Site

Bojnice, Slovak Republic, 972 01, Slovakia

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Humenné, Slovak Republic, 066 01, Slovakia

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Novartis Investigative Site

Liptovský Hrádok, Slovak Republic, 033 01, Slovakia

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Novartis Investigative Site

Nitra, Slovak Republic, 949 01, Slovakia

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Novartis Investigative Site

Vráble, Slovak Republic, 952 01, Slovakia

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Novartis Investigative Site

Galanta, Slovakia, 92422, Slovakia

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Košice, Slovakia, 040 01, Slovakia

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Košice, Slovakia, 04001, Slovakia

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Kráľovský Chlmec, Slovakia, 077 01, Slovakia

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Prešov, Slovakia, 080 01, Slovakia

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Prievidza, Slovakia, 97101, Slovakia

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Zvolen, Slovakia, 960 01, Slovakia

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Martin, 036 01, Slovakia

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Spisská Nová Ves, 052 01, Slovakia

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Novartis Investigative Site

Golnik, 4204, Slovenia

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Related Publications (1)

• 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

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: October 19, 2012
• First Posted: October 23, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 15, 2015
• Results First Posted: July 15, 2015

Record last verified: 2015-07

Locations

EG (1); SL (15); CO (3); PA (1); GU (3); HU (11); US (56); FR (4)