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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

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

Key facts

Study ID

NCT01712516

Run by

Novartis Pharmaceuticals

People needed

1001

Starts

2012-12-01

Expected to finish

2014-02-01

Last updated by the study team

2015-07-15

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — *See Various Dept.'s*, Arizona, United States
• Novartis Investigative Site — Tempe, Arizona, United States
• Novartis Investigative Site — Buena Park, California, United States
• Novartis Investigative Site — Fullerton, California, United States
• Novartis Investigative Site — Palmdale, California, United States
• Novartis Investigative Site — Riverside, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Sepulveda, California, United States
• Novartis Investigative Site — Clearwater, Florida, United States
• Novartis Investigative Site — Clearwater, Florida, United States
• Novartis Investigative Site — DeLand, Florida, United States
• Novartis Investigative Site — Fort Lauderdale, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Pensacola, Florida, United States
• Novartis Investigative Site — Pensacola, Florida, United States
• Novartis Investigative Site — Port Orange, Florida, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — Tamarac, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Winter Park, Florida, United States
• Novartis Investigative Site — Lawrenceville, Georgia, United States
• Novartis Investigative Site — Opelousas, Louisiana, United States
• Novartis Investigative Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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