A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557466
• Other study ID #: CQMF149B2201
• Status: Completed
• Phase: Phase 2
• First received: November 13, 2007
• Last updated: December 12, 2012
• Start date: October 2007
• Est. completion date: May 2008

Study information

• Verified date: November 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyIreland: Irish Medicines BoardItaly: The Italian Medicines AgencyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthNorway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencySouth Africa: Medicines Control CouncilSweden: Medical Products AgencyTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaChile: Comisión Nacional de Investigación Científica y TecnológicaPeru: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• indacaterol
Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
• formoterol
Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.
• placebo to indacaterol
Placebo TWISTHALER® device
• placebo to formoterol
Placebo AEROLIZER® device
• short acting ß2- agonist
100 µg / 90 µg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

Locations

Country	Name	City	State
Argentina	Novartis Investigator site	Buenos Aires
Argentina	Novartis Investigator Site	Rosario
Argentina	Novartis Investigator Site	Santillan
Belgium	Novartis Investigator Site	Liege
Chile	Novartis Investigator Site	Santiago
Chile	Novartis Investigator Site	Santiago de Chile
Chile	Novartis Investigator Site	Val Pariso
France	Novartis Investigator Site	Bois-Guillaume
France	Novartis Investigator Site	Clermot Ferand
France	Novartis Investigator Site	Lille
France	Novartis Investigator Site	Marseille
France	Novartis Investigator Site	Nante
France	Novartis Investigator site	Toulouse
Germany	Novartis Investigator Site	Berlin
Germany	Novartis Investigator site	Bibertal
Germany	Novartis Investigator Site	Bochum
Germany	Novartis Investigator Site - 2 sites	Bonn
Germany	Novartis Investigator Site	Frankfurt
Germany	Novartis Investigator Site	Hamburg
Germany	Novartis Investigator Site	Heidelberg
Germany	novartis Investigator site	Koblenz
Germany	Novartis Investigator Site	Koln
Germany	Novartis Investigator Site	Marburg
Germany	Novartis Investigator Site	Solingen
Hungary	Novartis Investigator Site	Budapest
Hungary	Novartis Investigator Site	Debrecen
Hungary	Novartis investigator site	Pecs
Ireland	Novartis investigator site	Dublin
Italy	Novartis Investigator Site	Genova
Italy	Novartis Investigator Site	Napoli
Italy	Novartis Investigator Site	Pordenone
Latvia	Novartis investigator site	Daugavpils
Latvia	Novartis Investigator Site	Riga
Lithuania	Novartis Investigator Site	Kaunas
Lithuania	Novartis Investigator Site	Klaipeda
Lithuania	Novartis Investigator Site	Vilnius
Norway	Novartis Investigator Site	Tronheim
Peru	Novartis Investigator Site	Lima
Poland	Novartis Investigator Site	Izabelin
Poland	Novartis Investigator Site	Lodz
Poland	Novartis Investigator Site	Lublin
Poland	Novartis Investigator site	Mrozy
Poland	Novartis Investigator Site	Olsztyn
Poland	Novartis Investigator Site	Rzeszow
Poland	Novartis Investigator Site	Wejhrowo
Poland	Novartis Investigator Site	Wloclawek
Romania	Novartis Investigator Site	Bucharest
Romania	Novartis Investigator Site	Bucuresti
Romania	Novartis Investigator Site	Cluj-napoca
Romania	Novartis Investigator Site	Iasi
Romania	Novartis Investigator Site	Timisoara
South Africa	Novartis Investigator Site	Amanzimtoti
South Africa	Novartis Investigator Site	Bloemfontain
South Africa	Novartis Investigator Site	Bloemfontein
South Africa	Novartis Investigator Site	Cape Town
South Africa	Novartis Investigator Site	Durban
South Africa	Novartis Investigator Site	George
South Africa	Novartis Investigator Site	Johannesburg
South Africa	Novartis Investigator Site	Port Elizabeth
South Africa	Novartis Investigator Site	Pretoria
South Africa	Novartis Investigator Site	Tygerberg
Turkey	Novartis Investigator Site	Erzurum
Turkey	Novartis Investigator Site	Isparta
Turkey	Novartis Investigator Site	Istanbul
Turkey	Novartis Investigator Site	Kahramanmaras
Turkey	Novartis Investigator Site	Kayseri
Turkey	Novartis Investigator Site	Malatya
Turkey	Novartis Investigator Site	Manisa
Turkey	Novartis Investigator Site	Trabzon
Turkey	Novartis Investigator Site	Urfa
United Kingdom	Novartis Investigator Site	Belfast
United Kingdom	Novartis Investigator Site	Chesterfield
United Kingdom	Novartis Investigator Site	Glasgow
United Kingdom	Novartis Investigator Site	Plymouth
United Kingdom	Novartis Investigator Site	Warminster
United Kingdom	Novartis investigator site	Watford
United Kingdom	Novartis Investigator Site	Whitstable

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Schering-Plough

Countries where clinical trial is conducted

Argentina,  Belgium,  Chile,  France,  Germany,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania,  Norway,  Peru,  Poland,  Romania,  South Africa,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)	FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.	Baseline (prior to first dose) and Day 15 (24 hours after last dose)	No
Secondary	Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose	FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.	Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.	No
Secondary	The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1	FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.	Day 1 Baseline (prior to first dose) and 24 hours post-dose.	No
Secondary	Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1	FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.	Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.	No
Secondary	Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14	FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.	Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose	No
Secondary	Change From Baseline in Morning and Evening Peak Expiratory Flow	The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter prior to taking study medication and recorded measurements in a diary every morning and evening during the study. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.	Baseline (recorded during the screening period) and Days 1-14 (treatment period).	No
Secondary	Number of Participants Using Rescue Medication	Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.	Over 14 days	No