COPD Clinical Trial
Official title:
Dose Escalation Study to Assess the Safety and Tolerability of Incremental Doses of QAB149 in Adults With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)
Verified date | October 2011 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | September 2005 |
Est. primary completion date | September 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
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 exclusion criteria apply. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Radiant Research | Boise | Idaho |
United States | Radiant Research | Encinitas | California |
Lead Sponsor | Collaborator |
---|---|
Novartis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety variables (laboratory tests, ECG, adverse events) | |||
Secondary | Lung function tests | |||
Secondary | Pharmacokinetics |
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