Loading clinical trials...

Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

A Phase III, Randomized, Double-blind, Triple-dummy, Placebo Controlled, Multicenter, 5-period, Single-dose Complete Block Crossover Study to Determine the Onset of Action of Indacaterol (150 and 300 μg) in Patients With Moderate to Severe COPD Using Salbutamol (200 μg) and Salmeterol/Fluticasone (50/500 μg) as Active Controls

NCT00669617•Novartis

View on ClinicalTrials.gov

Summary

This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
•Patients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the GOLD Guidelines, 2006) and:
•* Smoking history of at least 20 pack years
•* 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%, where FVC is forced vital capacity ('Post-' refers to 15-30 minutes after inhalation of 400 μg of salbutamol at Visit 2)

Exclusion Criteria

•Pregnant / nursing women or women of child-bearing potential
•Long term oxygen therapy (more than 15 hours per day) on a daily basis for chronic hypoxemia
•Patients hospitalized for COPD exacerbation in 6 weeks prior to Visit 2 and up to Visit 3
•Respiratory tract infection within 6 weeks prior to Visit 2 and up to Visit 3
•Concomitant pulmonary disease, pulmonary tuberculosis (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis
•Any history of asthma, including: blood eosinophil count \>400/mm3; onset of asthma symptoms prior to age 40 years
•History of long QT syndrome or whose QTc (Bazett's) measured at Visit 2 or Visit 3 is prolonged (\>450ms for males or \>470ms for females)
•Clinically relevant lab abnormalities / conditions such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the investigator's opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
•Uncontrolled Type I / Type II Diabetes or blood glucose outside normal or HbA1c \>8.0% of total hemoglobin measured at Visit 2
•Any patient with lung cancer or any active cancer or a history of cancer with less than 5 years disease-free survival time
+5 more criteria

Locations (17)

Novartis Investigative Site

Tamarac, Florida, United States

Novartis Investigator Site

Lafayette, Louisiana, United States

Novartis Investigative Site

Saint Charles, Missouri, United States

Novartis Investigative site

Shelby, North Carolina, United States

Novartis Investigative Site

Beaver, Pennsylvania, United States

Novartis Investigative Site

Antwerp, Belgium

Novartis Investigative Site

Berlin, Germany

Novartis Investigator Site

Borstel, Germany

Novartis Investigative site

Dortmund, Germany

Novartis Investigative site

Hamburg, Germany

Key Dates

Start Date

April 1, 2008

Primary Completion Date

August 1, 2008

Completion Date

August 1, 2008

Last Updated

September 12, 2011

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Indacaterol

DRUG

Salmeterol/fluticasone (50/500 μg)

DRUG

Salbutamol (200 µg)

DRUG

Placebo to Indacaterol

DRUG

Placebo to Salmeterol/fluticasone

DRUG

Placebo to salbutamol

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

View study

RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Probiotics in Pulmonaty Rehabilitation for COPD

A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease