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