Study to Assess the Safety and Tolerability of Incremental Doses of QAB149 in Adults With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00129831

Last Updated: 2011-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2005-09-30

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.

Conditions

COPD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

QAB149

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

Radiant Research

Encinitas, California, United States

Radiant Research

Boise, Idaho, United States

Countries

United States

Other Identifiers

CQAB149B2202

Identifier Type: -

Identifier Source: org_study_id