A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 out patients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:
1. Smoking history of at least 10 pack years (current or previous smokers)
2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥30% of the predicted normal value.
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 for chronic hypoxemia
Patients who have had a respiratory tract infection within 6 weeks prior to Visit
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II
Any patient with lung cancer or a history of lung cancer
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 (Bazett's) measured at Visit 1 or randomization is prolonged
Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
Patients unable to successfully use a dry powder inhaler device, MDI or perform spirometry measurements
Clareo Health | A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
