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

Phase 2

Completed

• Conditions: COPD

• Registration Number: NCT00129831
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-08-11
• Study First Submitted QC: 2005-08-11
• Study First Posted: 2005-08-12
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-24
• Last Update Posted: 2011-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety variables (laboratory tests, ECG, adverse events)

Secondary Outcome Measures

Name	Time	Method
Lung function tests
Pharmacokinetics

Trial Locations

Locations (1)

Radiant Research; 🇺🇸 Boise, Idaho, United States