Efficacy and Safety Study of Formoterol/Fluticasone and Salmeterol/Fluticasone in Patients With Moderate-to-severe COPD

NCT01393145 | Withdrawn Phase 3

• 1 other identifier: ACH-LLN-03(06/10)
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Keywords

Chronic obstructive pulmonary disease (COPD); salmeterol; fluticasone; formoterol; FEV1; Moderate-to-severe

Outcome Measures

Primary Outcomes (1)

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

  Changes of lung function parameter

  Comparative between baseline and week 24

Secondary Outcomes (3)

• Changes in forced expiratory volume in first second, without bronchodilator

  Week 0, 8, 16 and 24

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

Drug: Combination Fluticasone /Formoterol 12/250 μg

Group 2

ACTIVE COMPARATOR

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

Interventions

Combination Fluticasone /Formoterol 12/250 μg DRUG

Capsules containing Fumarate formoterol 12 µg + fluticasone propionate 250 µg dry powder for inhalation with aerocaps®

Group 1

Seretide Diskus (salmeterol/fluticasone) 50/250 μg DRUG

Capsules containing salmeterol xinafoate 72.5 µg (equivalent to 50 µg of salmeterol) presented as powder for aspiration, packed in a plastic device in disk format, containing 60 doses

Group 2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Need for long-term oxygen therapy (defined as the need for oxygen therapy ≥ 12 hours / day);
• Pregnant or test β-HCG serum positive;
• Lactating women;
• Subject who uses more than 2 alcohol drinks a day or\> 14 drinks a week;
• Subject with a history of malignancy or ≤ 5 years\> 5 years, but without documentation of remission / cure.

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate; Salmeterol Xinafoate; Fluticasone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Albuterol; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: July 13, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 15, 2017

Record last verified: 2017-02