Status:
COMPLETED
Study to Assess the Safety and Tolerability of Incremental Doses of QAB149 in Adults With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis
Conditions:
COPD
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00129831
Start Date
September 1 2004
End Date
September 1 2005
Last Update
October 25 2011
Active Locations (2)
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1
Radiant Research
Encinitas, California, United States, 92024
2
Radiant Research
Boise, Idaho, United States, 83704