Skip to main content
OpenTrials
Completed

NCT Number: NCT00615459

A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative site, Camperdown, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
  • Co-operative out patients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:
  • Smoking history of at least 10 pack years (current or previous smokers)
  • Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥30% of the predicted normal value.
  • Post-bronchodilator FEV1/Forced vital capacity (FVC) < 70%

Exclusion criteria

  • Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
  • Patients requiring long-term oxygen therapy for chronic hypoxemia
  • Patients who have had a respiratory tract infection within 6 weeks prior to Visit
  • Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Any patient with lung cancer or a history of lung cancer
  • Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
  • Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at Visit 1 or randomization is prolonged
  • Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
  • Patients unable to successfully use a dry powder inhaler device, MDI or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Indacaterol

Drug

Indacaterol 150 μg or 300 μg, delivered via SDDPI

Tiotropium

Drug

Tiotropium 18 μg once daily delivered via inhalation device

Placebo

Drug

Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)

Primary outcomes

  1. 24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment

    Time frame: 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of FEV1 measurements at 23 h 10 min and 23 h 45 min post Day 14 dose measured on the morning of Day 15 in each treatment period. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.

Secondary outcomes

  1. Peak FEV1 During 4 Hours Post Morning Dose on Day 1

    Time frame: Day 1 (from 0 to 4 hours post morning dose)

    FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect on Day 1 was defined as the maximum FEV1 during the first 4 hour on that day. FEV1 measurements taken within 6 hour of rescue use were set to missing before the peak FEV1 (0-4 hour) was calculated. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Phase III, Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, 3-period Incomplete Block, Multidose Crossover Study to Determine the Effect on Lung Function of Indacaterol (150 and 300 μg o.d.) in Patients With Moderate to Severe COPD, Using Tiotropium (18 μg o.d.) as an Active Control

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 14, 2008
Registry last updated
Aug 17, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.