Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Completed · Phase 4 · Has a placebo group

Conditions studied: COPD

In brief

This is a phase IV study of indacaterol 75 μg single-dose compared to placebo in moderate-severe COPD patients with breathing symptoms to assess time to patient's perception of onset of effect.

Key facts

Study ID

NCT01543828

Run by

Novartis Pharmaceuticals

People needed

40

Starts

2012-01-01

Expected to finish

2012-03-01

Last updated by the study team

2013-05-10

Who can join

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

You may qualify if…

• Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
• Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2008) and:
• Smoking history of at least 10 pack-years
• Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 70% and ≥ 40% of the predicted normal value
• Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
• Breathing symptoms that interfere with daily activities

You may not qualify if…

• Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
• Patients who have had a respiratory tract infection within 6 weeks prior to screening
• Patients who require oxygen therapy for chronic hypoxemia, are receiving bronchodilators or other medications for COPD that are dosed once daily, are unable to follow instruction on rescue albuterol use during the study, or are at risk deterioration of COPD with study procedures. Patients with concomitant pulmonary disease
• Patients with a history of asthma
• Patients with uncontrolled diabetes mellitus
• Any patient with lung cancer or a history of lung cancer
• Patients with a history of certain cardiovascular co-morbid conditions
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — Fullerton, California, United States
• Novartis Investigative Site — Saint Charles, Missouri, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Raleigh, North Carolina, United States
• Novartis Investigative Site — Columbus, Ohio, United States
• Novartis Investigative Site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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