26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive, COPD, Lung Diseases, Obstructive

In brief

Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD

Key facts

Study ID

NCT00463567

Run by

Novartis

People needed

2059

Starts

2007-04-01

Expected to finish

2008-08-01

Last updated by the study team

2011-08-18

Who can join

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

You may qualify if…

• Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
• Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and:
• Smoking history of at least 20 pack years
• Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value.
• Post-bronchodilator FEV1/FVC < 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol)

You may not qualify if…

• Pregnant or lactating females
• Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
• Patients requiring long term oxygen therapy (> 15 h a day)
• Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria)
• Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
• Patients with a history of asthma (with further criteria)
• Patients with Type I or uncontrolled Type II diabetes
• Patients with contraindications for tiotropium
• Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
• Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
• Patients with a history of long QT syndrome or whose QTc interval is prolonged
• Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures
• Patients who have had treatment with the investigational drug (with further criteria)
• Patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period
• Patients with known history of non compliance to medication
• Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Pulmonary Medicine Associates PC — Homewood, Alabama, United States
• Jasper Summit Research — Jasper, Alabama, United States
• Pulmonary Associate of Mobile, PC — Mobile, Alabama, United States
• Pulmonary Associates, PA — Glendale, Arizona, United States
• Pulmonary Associates, PA — Phoenix, Arizona, United States
• Novartis Investigative Center — Scottsdale, Arizona, United States
• Arizona Pulmonary Specialists, LTD — Scottsdale, Arizona, United States
• Premiere Pharmaceutical Research, LLC — Tempe, Arizona, United States
• Canyon Clinical Research, LLC — Tucson, Arizona, United States
• SAVAHSC / Pulmonary Section — Tucson, Arizona, United States
• Novartis Investigator Site — Pine Bluff, Arkansas, United States
• Novartis Investigator Site — Buena Park, California, United States
• USC Rancho Amigos Medical Center — Downey, California, United States
• Encompass Clinical Research - North Coast — Encinitas, California, United States
• California Research — Fullerton, California, United States
• Allergy and Asthma Specialists Medical Group and research Center — Huntington Beach, California, United States
• Interlink Research Institute — Los Alamitos, California, United States
• Allergy Research Foundation, Inc — Los Angeles, California, United States
• Novartis Investigator Site — Los Angeles, California, United States
• Southern California Institute for Respiratory Diseases — Los Angeles, California, United States
• David Geffen UCLA School of Medicine — Los Angeles, California, United States
• Advance Clinical Research Institute — Orange, California, United States
• California Allergy & Asthma Medical Group — Palmdale, California, United States
• Pinnacle Research Group, LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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