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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00129831
First received: August 11, 2005
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
COPD
Drug: QAB149
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety variables (laboratory tests, ECG, adverse events)

Secondary Outcome Measures:
  • Lung function tests
  • Pharmacokinetics

Enrollment: 6
Study Start Date: September 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129831

Locations
United States, California
Radiant Research
Encinitas, California, United States, 92024
United States, Idaho
Radiant Research
Boise, Idaho, United States, 83704
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00129831     History of Changes
Other Study ID Numbers: CQAB149B2202
Study First Received: August 11, 2005
Last Updated: October 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
COPD, indacaterol, PK

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014