COPD
Conditions
Keywords
COPD, indacaterol, PK
Brief summary
The purpose of this study is to determine the safety and tolerability of single doses of QAB149 up to 3000 µg delivered via a single-dose, dry powder inhaler in patients with mild to moderate COPD.
Interventions
DRUGQAB149
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and/or female patients with mild to moderate stable COPD, diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines; 40-75 years of age * Prebronchodilator baseline forced expiratory volume in 1 second (FEV1) 30-80% of the Quanjer predicted normal value (Quanjer et al. 1993) and at least 0.75 L with FEV1/forced vital capacity (FVC) \< 70% of predicted \[GOLD guidelines\]. * Previous smokers (\>10 pack-years). Ten pack years are defined as: 20 cigarettes a day for 10 years; 10 cigarettes a day for 20 years; or 40 cigarettes a day for 5 years. Current smokers, with \>10 pack year history, can be included under certain conditions. * Vital signs (after 3 minutes resting measured in the supine position) which are within the following ranges: * oral body temperature between 35.0-37.5 °C; * systolic blood pressure, 100-170 mm Hg; * diastolic blood pressure, 50-100 mm Hg; * pulse rate, 50 - 90 beats per minute (bpm). * Patients must weigh a minimum of 50 kg to participate in this study. * Able to provide written informed consent prior to study participation. * Able to communicate well with the investigator and comply with the requirements of the study.
Exclusion criteria
* Pregnant women or nursing mothers. * Patients with a QTc interval above 0.43 seconds for males and 0.45 seconds for females at the screening visit. If pre-treatment values on Day 1 of the treatment periods exceed 0.45 and 0.47 seconds for males and females respectively the visit may be re-scheduled once. * Patients with a history of prolonged QTc intervals, or a family history of prolonged QT syndrome. * Predominant diagnosis of asthma. (Patients must present without evidence of active asthma.) * Patients who have been hospitalized or had emergency treatment for acute COPD exacerbation in the one month prior to or during screening. * Patients who have had a respiratory tract infection within one month prior to screening. * Patients with concomitant pulmonary disease, including a history of cancer Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety variables (laboratory tests, ECG, adverse events) | — |
Secondary
| Measure | Time frame |
|---|---|
| Lung function tests | — |
| Pharmacokinetics | — |
Countries
United States
Outcome results
None listed