Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

Persistent Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156844
• Other study ID #: CQAB149B2223
• Secondary ID: 2010-018481-22
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2010
• Last updated: July 22, 2011
• Start date: March 2010

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesJordan: Jordanian FDANetherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Persistent Asthma

Intervention

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

Locations

Country	Name	City	State
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Rennes
Germany	Novartis Investigative Site	Wiesbaden
Jordan	Novartis Investigative Site	Amman
Jordan	Novartis Investigative Site	Irbid
Netherlands	Novartis Investigative Site	Groningen
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Merthyr Tydfil
United States	Novartis Investigative Site	Anniston	Alabama
United States	Novartis Investigative Site	Berlin	New Jersey
United States	Novartis Investigative Site	Clearwater	Florida
United States	Novartis Investigative Site	Cypress	California
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Fresno	California
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Lafayette	Louisiana
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Normal	Illinois
United States	Novartis Investigator Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Plano	Texas
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Sarasota	Florida
United States	Novartis Investigative Site	Tacoma	Washington
United States	Novartis Investigative Site	Tacoma	Washington
United States	Novartis Investigative Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Germany,  Jordan,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to week 2	No
Primary	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.	Baseline, 0-24 hours post dose week 2	No
Primary	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.	Baseline, 0 to 48 hours post dose week 2	No
Secondary	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.	Baseline, 0 to 12 hours post dose week 2	No