Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)

CompletadoFase 4ClinicalTrials.gov

ID: NCT01443845Tipo: INTERVENTIONALInicio: 30 de sept de 2011Fin estimado: 31 de ene de 2016

Traducción no disponible, mostrando original

Resumen

To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

\. Male or female patients at least 40 years of age
\. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted)
\. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) \< 70% at Screening (Visit 1)
\. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
\. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
\. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
\. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years

Criterios de exclusión

\. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)
\. Body mass index (BMI) ≥ 45 kg/m2
\. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable)
\. Known alpha-1-antitrypsin deficiency
\. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer

Intervenciones

drug

Roflumilast

Roflumilast 500 µg, oral administration, once per day

drug

Placebo

Dose-matched placebo, oral administration, once per day.

Ubicaciones

Forest Investigative Site 403

Buenos Aires, Buenos Aires, Argentina

Forest Investigative Site 418

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Forest Investigative Site 402

Florida, Buenos Aires, Argentina

Forest Investigative Site 405

La Plata, Buenos Aires, Argentina

Forest Investigative Site 406

Lanús Este, Buenos Aires, Argentina

Forest Investigative Site 413

Mar del Plata, Buenos Aires, Argentina

Forest Investigative Site 407

Paraná, Entre Ríos Province, Argentina

Forest Investigative Site 404

Mendoza, Mendoza Province, Argentina

Forest Investigative Site 412

Rosario, Santa Fe Province, Argentina

Forest Investigative Site 409

Rosario, Santa Fe Province, Argentina

Forest Investigative Site 411

Buenos Aires, Argentina

Forest Investigative Site 414

Buenos Aires, Argentina

Forest Investigative Site 419

Buenos Aires, Argentina

Forest Investigative Site 416

Buenos Aires, Argentina

Forest Investigative Site 415

Derqui Pilar - Buenos Aires, Argentina

Forest Investigative Site 417

La Plata, Argentina

Forest Investigative Site 420

Mendoza, Argentina

Forest Investigative Site 410

San Juan Bautista, Argentina

Forest Investigative Site 401

San Miguel de Tucumán, Argentina

Forest Investigative Site 408

Santa Fe, Argentina

Patrocinadores

PrincipalAstraZeneca

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