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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129831
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : October 25, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
COPD Drug: QAB149 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : September 2004
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases
Drug Information available for: Indacaterol

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

Secondary Outcome Measures :
  1. Lung function tests
  2. Pharmacokinetics

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129831

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

Layout table for additonal information Identifier: NCT00129831    
Other Study ID Numbers: CQAB149B2202
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: October 2011
Keywords provided by Novartis:
COPD, indacaterol, PK
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases