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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) | Clinical Trials | Clareo Health

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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)

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)

NCT00129831•Novartis

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 75 years

Sex

ALL

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.
+1 more criteria

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

Locations (2)

Radiant Research

Encinitas, California, United States

Radiant Research

Boise, Idaho, United States

Key Dates

Start Date

September 1, 2004

Primary Completion Date

September 1, 2005

Completion Date

September 1, 2005

Last Updated

October 25, 2011

Enrollment

ACTUAL participants

Conditions

COPD

Interventions

QAB149

DRUG

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Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

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COPD

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RECRUITINGNA

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COPD Exacerbation

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 25, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

Effect of Telenursing on Oral Health

Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD

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