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Completed

NCT Number: NCT00396604

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Novartis

Vilvoorde, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indacaterol maleate

Drug

Primary outcomes

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

Secondary outcomes

  1. FEV1 at time points 30 min, 1, 2 and 4hours post-dose

  2. Percent change in FEV1 at time points 30 min, 1, 2 and 4 hours, 23 hours 10min and 23 hours 45 min post dose

  3. 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

  4. Standardized FEV1 area under the curve (AUC) between baseline and 4 hours

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 7, 2006
Registry last updated
Oct 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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