Study to Assess the Safety and Tolerability of Incremental Doses of QAB149 in Adults With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)
Completed · Phase 2
Conditions studied: COPD
In brief
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.
Key facts
- Study ID
- NCT00129831
- Run by
- Novartis
- People needed
- 6
- Starts
- 2004-09-01
- Expected to finish
- 2005-09-01
- Last updated by the study team
- 2011-10-25
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 exclusion criteria apply.
Where it is running
- Radiant Research — Encinitas, California, United States
- Radiant Research — Boise, Idaho, United States
Full record on ClinicalTrials.gov
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