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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014