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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

NCT ID: NCT01712516

Last Updated: 2015-07-15

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1001 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-02-28

Brief Summary

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

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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QVA149

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

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

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

QAB149

27.5 ug b.i.d.

Group Type ACTIVE_COMPARATOR

QAB149

Intervention Type DRUG

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

NVA237

12.5 ug b.i.d.

Group Type ACTIVE_COMPARATOR

NVA237

Intervention Type DRUG

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

Placebo

b.i.d.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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QVA149

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

Intervention Type DRUG

QAB149

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

Intervention Type DRUG

NVA237

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Huntsville, Alabama, United States

Site Status

Novartis Investigative Site

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

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Tempe, Arizona, United States

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Buena Park, California, United States

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Fullerton, California, United States

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Palmdale, California, United States

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Riverside, California, United States

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San Diego, California, United States

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Sepulveda, California, United States

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Clearwater, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Pensacola, Florida, United States

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Port Orange, Florida, United States

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Sarasota, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Lawrenceville, Georgia, United States

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Opelousas, Louisiana, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Brandon, New Jersey, United States

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Charlotte, North Carolina, United States

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Huntersville, North Carolina, United States

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Raleigh, North Carolina, United States

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Shelby, North Carolina, United States

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Shelby, North Carolina, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Easley, South Carolina, United States

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Gaffney, South Carolina, United States

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Greenville, South Carolina, United States

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Pelzer, South Carolina, United States

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Rock Hll, South Carolina, United States

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Seneca, South Carolina, United States

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Simpsonville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Union, South Carolina, United States

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Johnson City, Tennessee, United States

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Arlington, Texas, United States

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Corsicana, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Fort Worth, Texas, United States

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Lufkin, Texas, United States

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McKinney, Texas, United States

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Tyler, Texas, 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, , Egypt

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Beuvry, France, France

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Nantes, , France

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Paris, , France

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Reims, , France

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Guatemala City, Departamento de Guatemala, Guatemala

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Guatemala City, Departamento de Guatemala, Guatemala

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Guatemala City, Departamento de Guatemala, Guatemala

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Balassagyarmat, Hungary, Hungary

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Debrecen, Hungary, Hungary

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Komárom, Hungary, Hungary

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Tatabánya, Hungary, Hungary

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Deszk, , Hungary

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Gödöllő, , Hungary

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Győr, , Hungary

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Makó, , Hungary

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Miskolc, , Hungary

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Százhalombatta, , Hungary

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Szombathely, , Hungary

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Panama City, Provincia de Panamá, Panama

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Bardejov, Slovak Republic, Slovakia

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Bojnice, Slovak Republic, Slovakia

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Humenné, Slovak Republic, Slovakia

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Liptovský Hrádok, Slovak Republic, Slovakia

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Nitra, Slovak Republic, Slovakia

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Vráble, Slovak Republic, Slovakia

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Galanta, Slovakia, Slovakia

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Košice, Slovakia, Slovakia

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Košice, Slovakia, Slovakia

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Kráľovský Chlmec, Slovakia, Slovakia

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Prešov, Slovakia, Slovakia

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Prievidza, Slovakia, Slovakia

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Zvolen, Slovakia, Slovakia

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Martin, , Slovakia

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Spisská Nová Ves, , Slovakia

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Golnik, , Slovenia

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Countries

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United States Colombia Egypt France Guatemala Hungary Panama Slovakia Slovenia

References

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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.

Reference Type DERIVED
PMID: 31539467 (View on PubMed)

Other Identifiers

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CQVA149A2337

Identifier Type: -

Identifier Source: org_study_id

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