Clinical trial NCT01609478: Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 12-week Treatment, Parallel-group Study to Assess the Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate (75 and 150 µg o.d.) in Patients With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-06-01
Enrollment: 335
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: To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.


Eligibility criteria: Inclusion Criteria:

* Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
* Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks
* Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value
* Patients who demonstrate an increase of \>= 12% and 200 mL in FEV1
* ACQ-5 score ≥ 1.5

Exclusion Criteria:

* Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
* Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.
* Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)
timeFrame: after 12 weeks (Day 85)
Secondary outcomes:
measure: Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)
timeFrame: aftert 12 weeks (Day 85)
measure: Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.
timeFrame: Day 15, Day 29 and Day 57
measure: Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points
timeFrame: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
measure: Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
timeFrame: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
measure: Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
timeFrame: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
measure: Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)
timeFrame: Day 1, 2 Weeks, 12 Weeks
measure: Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)
timeFrame: Day 1, 2 weeks (Day 14), 12 weeks (Day 84)
measure: Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment
timeFrame: after 4 weeks (Day 29) and after 8 weeks (Day 57)
measure: Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.
timeFrame: baseline, 4weeks, 8 weeks and 12 weeks
measure: The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment
timeFrame: 12 weeks
measure: Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment
timeFrame: 4 Weeks, 12 Weeks
measure: Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
timeFrame: 12 weeks
measure: The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
timeFrame: 12 weeks
measure: Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
timeFrame: 12 weeks
measure: The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
timeFrame: 12 weeks
measure: Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period
timeFrame: 12 weeks
measure: The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period
timeFrame: 12 weeks
measure: Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period
timeFrame: 12 weeks
measure: Plasma Indacaterol Concentrations at Day 1 and Day 14
timeFrame: Day 1 and Day 14
Other outcomes:
Locations:
city: Lovech
country: Bulgaria
facility: Novartis Investigative Site
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Ruse
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Veliko Tarnovo
country: Bulgaria
facility: Novartis Investigative Site
city: Brampton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Downsview
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Etobicoke
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Grimsby
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Newmarket
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Woodstock
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: St-Romuald
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Bad Woerishofen
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Lübeck
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Wiesloch
country: Germany
facility: Novartis Investigative Site
city: Yanagawa
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Obihiro
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Ako-shi
country: Japan
facility: Novartis Investigative Site
state: Hyogo-Ken
city: Himeji-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Naka-gun
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Sakaide
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Kyoto-shi
country: Japan
facility: Novartis Investigative Site
state: Kyoto-Fu
city: Tsu
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Oita-shi
country: Japan
facility: Novartis Investigative Site
state: Oita-Ken
city: Beppu
country: Japan
facility: Novartis Investigative Site
state: Oita
city: Kishiwada
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Machida-shi
country: Japan
facility: Novartis Investigative Site
state: Tokyo-To
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo-To
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Cyuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kiyose-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Yonezawa
country: Japan
facility: Novartis Investigative Site
state: Yamagata
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Gifu
country: Japan
facility: Novartis Investigative Site
city: Cheongju
country: Korea, Republic of
facility: Novartis Investigative Site
state: Chungbuk
city: Wonju
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gangwon-Do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Sittard-Geleen
country: Netherlands
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Bienkowka
country: Poland
facility: Novartis Investigative Site
city: Bydgoszcz
country: Poland
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Torun
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Znin
country: Poland
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Levice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak republic
city: Dunajska Streda
country: Slovakia
facility: Novartis Investigative Site
city: Komarno
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Liptovsky Hradok
country: Slovakia
facility: Novartis Investigative Site
city: Liptovsky Mikulas
country: Slovakia
facility: Novartis Investigative Site
city: Nove Zamky
country: Slovakia
facility: Novartis Investigative Site
city: Rimavska Sobota
country: Slovakia
facility: Novartis Investigative Site
city: Spisská Nová Ves
country: Slovakia
facility: Novartis Investigative Site
city: Topolcany
country: Slovakia
facility: Novartis Investigative Site
city: Vysne Hagy
country: Slovakia
facility: Novartis Investigative Site
city: Zvolen
country: Slovakia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: