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

Primary Purpose

COPD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
QAB149
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, indacaterol, PK

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Radiant Research
  • Radiant Research

Outcomes

Primary Outcome Measures

Safety variables (laboratory tests, ECG, adverse events)

Secondary Outcome Measures

Lung function tests
Pharmacokinetics

Full Information

First Posted
August 11, 2005
Last Updated
October 24, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00129831
Brief Title
Study to Assess the Safety and Tolerability of Incremental Doses of QAB149 in Adults With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, indacaterol, PK

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
QAB149
Primary Outcome Measure Information:
Title
Safety variables (laboratory tests, ECG, adverse events)
Secondary Outcome Measure Information:
Title
Lung function tests
Title
Pharmacokinetics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 Other exclusion criteria apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Radiant Research
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Radiant Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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