Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

COPD Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443845
• Other study ID #: ROF-MD-07
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2011
• Last updated: March 31, 2016
• Start date: September 2011
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaCanada: Health CanadaChile: Instituto de Salud Pública de ChileColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthMalaysia: Ministry of HealthMexico: Secretaria de SaludPeru: General Directorate of Pharmaceuticals, Devices, and DrugsPeru: Instituto Nacional de SaludPhilippines: Bureau of Food and DrugsRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSpain: Agencia Española de Medicamentos y Productos SanitariosTaiwan : Food and Drug AdministrationThailand: Food and Drug AdministrationUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2354
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 1. Male or female patients at least 40 years of age

• 2. 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)

• 3. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) < 70% at Screening (Visit 1)

• 4. FEV1 (postbronchodilator) = 50% of predicted at Screening (Visit 1)

• 5. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)

• 6. Patients must be on FDC LABA/ICS treatment = 3 months prior to Screening (Visit 1)

• 7. 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

Exclusion Criteria:

• 1. 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)

• 2. Known alpha-1-antitrypsin deficiency

• 3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)

• 4. Body mass index (BMI) = 45 kg/m2

• 5. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer

Study Design

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

Related Conditions & MeSH terms

• Chronic Obstructive Airway Disease
• Chronic Obstructive Lung Diseases
• COPD
• COPD Exacerbation
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease
• Pulmonary Disease, Chronic Obstructive
• Respiration Disorders
• Respiratory Disorders
• Respiratory Tract Diseases

Intervention

Drug:
• Roflumilast
Roflumilast 500 µg, oral administration, once per day
• Placebo
Dose-matched placebo, oral administration, once per day.

Locations

Country	Name	City	State
Argentina	Forest Investigative Site 403	Buenos Aires
Argentina	Forest Investigative Site 411	Ciudad Autonoma de Buenos Aires
Argentina	Forest Investigative Site 414	Ciudad Autonoma de Buenos Aires
Argentina	Forest Investigative Site 416	Ciudad Autonoma de Buenos Aires
Argentina	Forest Investigative Site 418	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Forest Investigative Site 419	Ciudad Autonoma de Buenos Aires
Argentina	Forest Investigative Site 415	Derqui Pilar - Buenos Aires
Argentina	Forest Investigative Site 410	Florencio Varela
Argentina	Forest Investigative Site 402	Florida	Buenos Aires
Argentina	Forest Investigative Site 405	La Plata	Buenos Aires
Argentina	Forest Investigative Site 417	La Plata
Argentina	Forest Investigative Site 406	Lanús Este	Provincia de Buenos Aires
Argentina	Forest Investigative Site 413	Mar del Plata	Buenos Aires
Argentina	Forest Investigative Site 404	Mendoza
Argentina	Forest Investigative Site 420	Mendoza
Argentina	Forest Investigative Site 407	Parana	Entre Rios
Argentina	Forest Investigative Site 409	Rosario	Santa Fe
Argentina	Forest Investigative Site 412	Rosario	Santa Fe
Argentina	Forest Investigative Site 401	San Miguel de Tucuman
Argentina	Forest Investigative Site 408	Santa Fe
Canada	Forest Investigative Site 302	Burlington	Ontario
Canada	Forest Investigative Site 235	Calgary	Alberta
Canada	Forest Investigative Site 185	Montreal	Quebec
Canada	Forest Investigative Site 162	North Vancouver	British Columbia
Canada	Forest Investigative Site 127	Saskatoon	Saskatchewan
Chile	Forest Investigative Site 421	Talcahuano
Colombia	Forest Investigative Site 442	Bogota
Colombia	Forest Investigative Site 443	Bogota
Italy	Forest Investigative Site 461	Chieti
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Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  Colombia,  Italy,  Malaysia,  Mexico,  Peru,  Philippines,  Romania,  Russian Federation,  Serbia,  Spain,  Taiwan,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of moderate or severe COPD exacerbations per subject per year		52 Weeks	No
Secondary	Prebronchodilator Forced Expiratory Volume in 1 second (FEV1) in Liters		Change from randomization, Week 0 (Visit 2) to Week 52	No