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Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Repeated-dose Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Three Different Dosing Regimens of Inhaled Indacaterol Maleate in Patients With Persistent Asthma

NCT01156844•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with a diagnosis of asthma and:
•Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
•FEV1 ≥50% and ≤90% of predicted normal at screening
•An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling a total dose of albuterol/salbutamol of 360/400 MDI

Exclusion Criteria

•Smoking history of ≥ 10 years
•Patients with a diagnosis of COPD
•Patients who have been previously intubated for a severe asthma exacerbation/ attack
•Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
•Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening
•Patients who have had a respiratory tract infection within 6 weeks prior to screening
•Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
•Patients with Type I or uncontrolled Type II diabetes mellitus

Locations (30)

Novartis Investigative Site

Anniston, Alabama, United States

Novartis Investigative Site

Cypress, California, United States

Novartis Investigative Site

Fresno, California, United States

Novartis Investigative Site

San Diego, California, United States

Novartis Investigative Site

Denver, Colorado, United States

Novartis Investigative Site

Clearwater, Florida, United States

Novartis Investigative Site

Miami, Florida, United States

Novartis Investigative Site

Miami, Florida, United States

Novartis Investigative Site

Sarasota, Florida, United States

Novartis Investigative Site

Tampa, Florida, United States

Key Dates

Start Date

March 1, 2010

Primary Completion Date

July 1, 2010

Last Updated

August 17, 2011

Enrollment

191

ACTUAL participants

Conditions

Persistent Asthma

Interventions

Indacaterol

DRUG

Placebo to Indacaterol

DRUG

Asthma Research in Children and Adolescents

NCT04480242

Persistent AsthmaAsthma in Children+1 more

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COMPLETEDPHASE2

Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation

NCT04773678

Moderate to Severe Persistent Asthma

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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: August 17, 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.

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Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

Inclusion Criteria

Exclusion Criteria

Asthma Research in Children and Adolescents

Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation

Efficacy, Safety, and Pharmacokinetics of QAW039

Study of Safety of Foradil in Patients With Persistent Asthma

OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma