Clinical trial NCT00557466: A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Multi-center, Parallel Group, Double Blind, Placebo and Formoterol Controlled 14 Day Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
Keywords: QMF
indacaterol
TWISTHALER® device
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Schering-Plough
First posted: 2007-11-14
Enrollment: 568
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.


Eligibility criteria: Inclusion Criteria:

* Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment)
* Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and:

  * Smoking history of at least 10 pack years
  * Post-bronchodilator Forced Expiratory Volume in one second (FEV1) \< 80% and ≥30% of the predicted normal value.
  * Post-bronchodilator FEV1/Forced vital capacity (FVC) \< 70%

Exclusion Criteria:

* Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.
* Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.
* Patients with a history of asthma.
* Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.
* Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline (prior to first dose) and Day 15 (24 hours after last dose)
Secondary outcomes:
measure: Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose
timeFrame: Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.
measure: The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1
timeFrame: Day 1 Baseline (prior to first dose) and 24 hours post-dose.
measure: Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1
timeFrame: Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.
measure: Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14
timeFrame: Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose
measure: Change From Baseline in Morning and Evening Peak Expiratory Flow
timeFrame: Baseline (recorded during the screening period) and Days 1-14 (treatment period).
measure: Number of Participants Using Rescue Medication
timeFrame: Over 14 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Novartis Investigator site
city: Rosario
country: Argentina
facility: Novartis Investigator Site
city: Santillan
country: Argentina
facility: Novartis Investigator Site
city: Liege
country: Belgium
facility: Novartis Investigator Site
city: Santiago de Chile
country: Chile
facility: Novartis Investigator Site
city: Santiago
country: Chile
facility: Novartis Investigator Site
city: Val Pariso
country: Chile
facility: Novartis Investigator Site
city: Bois-Guillaume
country: France
facility: Novartis Investigator Site
city: Clermot Ferand
country: France
facility: Novartis Investigator Site
city: Lille
country: France
facility: Novartis Investigator Site
city: Marseille
country: France
facility: Novartis Investigator Site
city: Nante
country: France
facility: Novartis Investigator Site
city: Toulouse
country: France
facility: Novartis Investigator site
city: Berlin
country: Germany
facility: Novartis Investigator Site
city: Bibertal
country: Germany
facility: Novartis Investigator site
city: Bochum
country: Germany
facility: Novartis Investigator Site
city: Bonn
country: Germany
facility: Novartis Investigator Site - 2 sites
city: Frankfurt
country: Germany
facility: Novartis Investigator Site
city: Hamburg
country: Germany
facility: Novartis Investigator Site
city: Heidelberg
country: Germany
facility: Novartis Investigator Site
city: Koblenz
country: Germany
facility: novartis Investigator site
city: Koln
country: Germany
facility: Novartis Investigator Site
city: Marburg
country: Germany
facility: Novartis Investigator Site
city: Solingen
country: Germany
facility: Novartis Investigator Site
city: Budapest
country: Hungary
facility: Novartis Investigator Site
city: Debrecen
country: Hungary
facility: Novartis Investigator Site
city: Pecs
country: Hungary
facility: Novartis investigator site
city: Dublin
country: Ireland
facility: Novartis investigator site
city: Genova
country: Italy
facility: Novartis Investigator Site
city: Napoli
country: Italy
facility: Novartis Investigator Site
city: Pordenone
country: Italy
facility: Novartis Investigator Site
city: Daugavpils
country: Latvia
facility: Novartis investigator site
city: Riga
country: Latvia
facility: Novartis Investigator Site
city: Kaunas
country: Lithuania
facility: Novartis Investigator Site
city: Klaipeda
country: Lithuania
facility: Novartis Investigator Site
city: Vilnius
country: Lithuania
facility: Novartis Investigator Site
city: Tronheim
country: Norway
facility: Novartis Investigator Site
city: Lima
country: Peru
facility: Novartis Investigator Site
city: Izabelin
country: Poland
facility: Novartis Investigator Site
city: Lodz
country: Poland
facility: Novartis Investigator Site
city: Lublin
country: Poland
facility: Novartis Investigator Site
city: Mrozy
country: Poland
facility: Novartis Investigator site
city: Olsztyn
country: Poland
facility: Novartis Investigator Site
city: Rzeszow
country: Poland
facility: Novartis Investigator Site
city: Wejhrowo
country: Poland
facility: Novartis Investigator Site
city: Wloclawek
country: Poland
facility: Novartis Investigator Site
city: Bucharest
country: Romania
facility: Novartis Investigator Site
city: Bucuresti
country: Romania
facility: Novartis Investigator Site
city: Cluj-napoca
country: Romania
facility: Novartis Investigator Site
city: Iasi
country: Romania
facility: Novartis Investigator Site
city: Timisoara
country: Romania
facility: Novartis Investigator Site
city: Amanzimtoti
country: South Africa
facility: Novartis Investigator Site
city: Bloemfontain
country: South Africa
facility: Novartis Investigator Site
city: Bloemfontein
country: South Africa
facility: Novartis Investigator Site
city: Cape Town
country: South Africa
facility: Novartis Investigator Site
city: Durban
country: South Africa
facility: Novartis Investigator Site
city: George
country: South Africa
facility: Novartis Investigator Site
city: Johannesburg
country: South Africa
facility: Novartis Investigator Site
city: Port Elizabeth
country: South Africa
facility: Novartis Investigator Site
city: Pretoria
country: South Africa
facility: Novartis Investigator Site
city: Tygerberg
country: South Africa
facility: Novartis Investigator Site
city: Erzurum
country: Turkey
facility: Novartis Investigator Site
city: Isparta
country: Turkey
facility: Novartis Investigator Site
city: Istanbul
country: Turkey
facility: Novartis Investigator Site
city: Kahramanmaras
country: Turkey
facility: Novartis Investigator Site
city: Kayseri
country: Turkey
facility: Novartis Investigator Site
city: Malatya
country: Turkey
facility: Novartis Investigator Site
city: Manisa
country: Turkey
facility: Novartis Investigator Site
city: Trabzon
country: Turkey
facility: Novartis Investigator Site
city: Urfa
country: Turkey
facility: Novartis Investigator Site
city: Belfast
country: United Kingdom
facility: Novartis Investigator Site
city: Chesterfield
country: United Kingdom
facility: Novartis Investigator Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigator Site
city: Plymouth
country: United Kingdom
facility: Novartis Investigator Site
city: Warminster
country: United Kingdom
facility: Novartis Investigator Site
city: Watford
country: United Kingdom
facility: Novartis investigator site
city: Whitstable
country: United Kingdom
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma AG
role: STUDY_CHAIR
References: