Clinical trial NCT01156844: Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Persistent Asthma
Keywords: Indacaterol
Asthma
Bronchodilation
Beta-agonist
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-07-05
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment
timeFrame: Baseline to week 2
measure: 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
timeFrame: Baseline, 0-24 hours post dose week 2
measure: 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
timeFrame: Baseline, 0 to 48 hours post dose week 2
Secondary outcomes:
measure: 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
timeFrame: Baseline, 0 to 12 hours post dose week 2
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Cypress
country: United States
facility: Novartis Investigative Site
state: California
city: Fresno
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Clearwater
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Sarasota
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tampa
country: United States
facility: Novartis Investigative Site
state: Florida
city: Normal
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Lafayette
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Berlin
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Raleigh
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Novartis Investigator Site
state: Oklahoma
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Plano
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
city: Paris
country: France
facility: Novartis Investigative Site
city: Rennes
country: France
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Amman
country: Jordan
facility: Novartis Investigative Site
city: Irbid
country: Jordan
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Merthyr Tydfil
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: