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

NCT00129831 | Completed Phase 2

• 1 other identifier: CQAB149B2202
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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

Keywords

COPD, indacaterol, PK

Outcome Measures

Primary Outcomes (1)

• Safety variables (laboratory tests, ECG, adverse events)

Secondary Outcomes (2)

• Lung function tests

• Pharmacokinetics

Interventions

QAB149 DRUG

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (2)

Radiant Research

Encinitas, California, 92024, United States

Location

Radiant Research

Boise, Idaho, 83704, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 11, 2005
• First Posted: August 12, 2005
• Study Start: September 1, 2004
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: October 25, 2011

Record last verified: 2011-10

Locations

US (2)