Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

Phase 2CompletedNCT01156844

Novartis Pharmaceuticals191 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

191

Conditions

Persistent Asthma

Interventions

IndacaterolDRUG

Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.

Placebo to IndacaterolDRUG

Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Other protocol-defined inclusion/exclusion criteria may apply

Locations (30)

Outcomes

Primary Outcomes

Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment

Spirometry was conducted according to internationally accepted standards. Trough FEV1 values were calculated as the mean of the 23.17 hours and 23.75 hours post morning dose FEV1 measurements. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.

Time frame: Baseline to week 2

Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 24 Hours Post Dose (FEV1 AUC 0-24h) After Two Weeks of Treatment

Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-24 hours) of FEV1 measurements taken at pre-dose to 24 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.

Time frame: Baseline, 0-24 hours post dose week 2

Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 48 Hours (FEV1 AUC 0-48h) After Two Weeks of Treatment

Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-48 hours) of FEV1 measurements taken at pre-dose to 48 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.

Time frame: Baseline, 0 to 48 hours post dose week 2

Secondary Outcomes

Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 12 Hours (FEV1 AUC 0-12h) After Two Weeks of Treatment

Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-12 hours) of FEV1 measurements taken at pre-dose to 12 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.

Data from ClinicalTrials.gov

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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

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Denver, Colorado, United States

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Clearwater, Florida, United States

Novartis Investigative Site

Miami, Florida, United States

Novartis Investigative Site

Miami, Florida, United States

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Sarasota, Florida, United States

Novartis Investigative Site

Tampa, Florida, United States

...and 20 more locations