Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)

October 24, 2011 updated by: Novartis

A Randomized, Double-blind, Double-dummy, Active (Formoterol 12 µg b.i.d) and Placebo Controlled, Multi-center, 5 Period Crossover Study to Assess the Bronchodilatory Efficacy and Safety of Single Doses of Indacaterol 150 µg, 300 µg and 600 µg Delivered Via Single Dose Dry Powder Inhaler vs. Placebo in Patients With Moderate to Severe COPD.

The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, once- indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Vilvoorde, Belgium
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and females aged 40-75 years with COPD and symptoms such as cough, sputum production, and shortness of breath.
  • Smoking history of at least 10 pack years
  • FEV1 less than 65% of the predicted normal value and at least 0.75 L
  • Pre-bronchodilator FEV1/FVC less than 70%

Exclusion Criteria:

  • A history of asthma or COPD diagnosis before the age of 40
  • Hospitalization for COPD exacerbation within the previous 6 weeks
  • Respiratory tract infection within 6 weeks
  • Use of long-term oxygen therapy
  • Diabetes type I or uncontrolled diabetes type II
  • Clinically relevant laboratory abnormality or clinically significant condition
  • Corrected QT interval (QTc) above 430 ms for males and 450 ms for females, or a history of QTc prolongation. Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Lung function measured 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second "(FEV1)

Secondary Outcome Measures

Outcome Measure
FEV1 at time points 30 min, 1, 2 and 4hours post-dose
Percent change in FEV1 at time points 30 min, 1, 2 and 4 hours, 23 hours 10min and 23 hours 45 min post dose
Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 hours, 23 hours 10 min and 23 hours 45 min post dose
Standardized FEV1 area under the curve (AUC) between baseline and 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Principal Investigator: Novartis, Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

November 6, 2006

First Submitted That Met QC Criteria

November 6, 2006

First Posted (Estimate)

November 7, 2006

Study Record Updates

Last Update Posted (Estimate)

October 25, 2011

Last Update Submitted That Met QC Criteria

October 24, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAB149B2212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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