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

CompletadoFase 2ClinicalTrials.gov

ID: NCT00557466Tipo: INTERVENTIONALInicio: 1 de oct de 2007Fin estimado: 1 de may de 2008

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

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%

Criterios de exclusión

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.

Intervenciones

drug

indacaterol

Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

drug

formoterol

Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.

drug

placebo to indacaterol

Placebo TWISTHALER® device

drug

placebo to formoterol

Placebo AEROLIZER® device

drug

short acting β2- agonist

100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

Ubicaciones

Novartis Investigator site

Buenos Aires, Argentina

Novartis Investigator Site

Rosario, Argentina

Novartis Investigator Site

Santillán, Argentina

Patrocinadores

PrincipalNovartis

ColaboradorSchering-Plough

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