Multicenter, Phase III, Randomized, Open Label Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Formoterol/Fluticasone and Salmeterol/Fluticasone in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).

Ache Laboratorios Farmaceuticos S.A.0 sitesAugust 2011

ConditionsChronic Obstructive Pulmonary Disease COPD

InterventionsCombination Fluticasone /Formoterol 12/250 μg Seretide Diskus (salmeterol/fluticasone) 50/250 μg

DrugsCombination Fluticasone /Formoterol 12/250 μg Seretide Diskus (salmeterol/fluticasone) 50/250 μg

Overview

Phase: Phase 3
Intervention: Combination Fluticasone /Formoterol 12/250 μg
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Ache Laboratorios Farmaceuticos S.A.
Primary Endpoint: Changes in pre-bronchodilator forced expiratory volume in first second (FEV1)
Status: Withdrawn
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A study multicenter, phase III, randomized, open label study to evaluate the efficacy and safety of a fixed-dose combination of formoterol/fluticasone and salmeterol/fluticasone in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) that will enroll 336 subjects aged ≥ 40 years, smokers or former smokers, diagnosed with chronic obstructive pulmonary disease, classified as moderate chronic obstructive pulmonary disease or severe according to GOLD spirometric classification. The subjects will be allocated in 2 parallel groups and will receive the medicines of study, according of the randomization during a 24-week.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

August 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ache Laboratorios Farmaceuticos S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 40 years;
•Chronic obstructive pulmonary disease classified as moderate or severe according to GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease), with post-bronchodilator FEV1/FVC \<0.70, and post-bronchodilator FEV1 \<80% and ≥ 30% predicted;
•Understanding and capacity to give written consent;
•Smoker or ex-smoker of ≥ 10 pack-years \[number of pack-years = number of daily cigarettes / 20 x number of years of smoking (eg t10 pack-years is equal to 20 cigarettes / day for 10 years, or 10 cigarettes per day within 20 years)\].
•Ability to fill out the patient's Diary
•Ability to fill out the MRC dyspnea scale and questionnaires CAT and CDLM.

Exclusion Criteria

•Presence of clinically associate morbidities manifested according to the investigator that would interfere in the evaluation, for example: diabetes mellitus, congestive heart failure, coronary heart disease, chronic renal failure, liver failure, arrhythmia, hypothyroidism or hyperthyroidism;
•Presence of neuro-psychiatric disorders of any kind;
•Presence of mental retardation of any etiology;
•Presence of pulmonary malformations, bronchiectasis, cystic fibrosis, bronchopulmonary hemosiderosis, ciliary dyskinesia, alveolitis, hypersensitivity, pulmonary vasculitis, sarcoidosis, tuberculosis or other lung diseases that might interfere with study assessments, as the investigator's discretion;
•Subjects using immunosuppressive therapy, immunomodulatory agents, chemotherapy for allergy or any other immunotherapy;
•Subjects using xanthine or acebrophylline;
•Use within two months preceding the screening visit (V-2) of: anti-leukotrienes, immunoglobulins (including omalizumab), beta blockers, digitalis, itraconazole, amiodarone, antidepressants, monoamine oxidase inhibitors, tricyclic antidepressants, rifampin, oral contraceptives and coumarin ;
•Current diagnosis of asthma;
•Symptomatic coronary insufficiency;
•Surgery for lung volume reduction and / or lung transplantation;

Arms & Interventions

Group 1

Intervention: Combination Fluticasone /Formoterol 12/250 μg

Group 2

Intervention: Seretide Diskus (salmeterol/fluticasone) 50/250 μg

Outcomes

Primary Outcomes

Changes in pre-bronchodilator forced expiratory volume in first second (FEV1)

Time Frame: Comparative between baseline and week 24

Changes of lung function parameter

Secondary Outcomes

Safety descriptive about occurence of adverse events, evaluation of results of clinical/physical examination and laboratory tests results(From baseline to week 24)
Changes in COPD Assessment Test (CAT)(Week 0, 8, 16 and 24)
Changes in forced expiratory volume in first second, without bronchodilator(Week 0, 8, 16 and 24)