Efficacy and Safety Study of Formoterol/Fluticasone and Salmeterol/Fluticasone in Patients With Moderate-to-severe COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease, COPD
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Combination Fluticasone /Formoterol 12/250 μg
Seretide Diskus (salmeterol/fluticasone) 50/250 μg
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease (COPD), salmeterol, fluticasone, formoterol, FEV1, Moderate-to-severe
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;
- 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.
- Illiterate or individuals who have limitation in understanding the use of devices as well as an inability to understand the questionnaires and diary that will be applied; Exception: subject illiterate, but capable of understanding regarding the use of the device, the questionnaires and diaries of the study and make available for relatives who can fill the diary study.
- History of hypersensitivity to study drugs and rescue;
- Any other disease or therapy that in the opinion of the investigator would jeopardize the subject or interfere with the objective of the study;
- Subject with a history of ineffectiveness of formoterol fumarate, to fluticasone or salmeterol xinafoate;
- Subject who participated in another study within 1 (one) year;
- Pregnant women or those with positive serum β-HCG;
- Radiological change is not compatible with COPD;
- Clinically significant ECG changes, as reported by the investigator;
- Any other disease, therapy or laboratory abnormality which in the opinion of the investigator would jeopardize the subject or interfere with the objective of the study;
- Use of medications prescribed in the exclusion criteria for visit V -2.
- Subjects who had an exacerbation during the standardization that required systemic corticosteroids and / or antibiotics or hospitalization will not be eligible for randomization.
- Use of oral corticosteroids, anti-leukotrienes, immunoglobulins (including omalizumab), beta blockers, digitalis, amiodarone, itraconazole, antidepressants, monoamine oxidase inhibitors and tricyclic antidepressants during the period of standardization;
- Any other disease or therapy that in the opinion of the investigator would jeopardize the subject or interfere with the objective of the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Outcomes
Primary Outcome Measures
Changes in pre-bronchodilator forced expiratory volume in first second (FEV1)
Changes of lung function parameter
Secondary Outcome Measures
Changes in forced expiratory volume in first second, without bronchodilator
Changes of lung function parameter
Safety descriptive about occurence of adverse events, evaluation of results of clinical/physical examination and laboratory tests results
Collection of safety data throughout the whole study period
Changes in COPD Assessment Test (CAT)
Questionnaire
Full Information
NCT ID
NCT01393145
First Posted
March 9, 2011
Last Updated
February 14, 2017
Sponsor
Ache Laboratorios Farmaceuticos S.A.
1. Study Identification
Unique Protocol Identification Number
NCT01393145
Brief Title
Efficacy and Safety Study of Formoterol/Fluticasone and Salmeterol/Fluticasone in Patients With Moderate-to-severe COPD
Official Title
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).
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ache Laboratorios Farmaceuticos S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD
Keywords
Chronic obstructive pulmonary disease (COPD), salmeterol, fluticasone, formoterol, FEV1, Moderate-to-severe
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Combination Fluticasone /Formoterol 12/250 μg
Intervention Description
Capsules containing Fumarate formoterol 12 µg + fluticasone propionate 250 µg dry powder for inhalation with aerocaps®
Intervention Type
Drug
Intervention Name(s)
Seretide Diskus (salmeterol/fluticasone) 50/250 μg
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in pre-bronchodilator forced expiratory volume in first second (FEV1)
Description
Changes of lung function parameter
Time Frame
Comparative between baseline and week 24
Secondary Outcome Measure Information:
Title
Changes in forced expiratory volume in first second, without bronchodilator
Description
Changes of lung function parameter
Time Frame
Week 0, 8, 16 and 24
Title
Safety descriptive about occurence of adverse events, evaluation of results of clinical/physical examination and laboratory tests results
Description
Collection of safety data throughout the whole study period
Time Frame
From baseline to week 24
Title
Changes in COPD Assessment Test (CAT)
Description
Questionnaire
Time Frame
Week 0, 8, 16 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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;
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.
Illiterate or individuals who have limitation in understanding the use of devices as well as an inability to understand the questionnaires and diary that will be applied; Exception: subject illiterate, but capable of understanding regarding the use of the device, the questionnaires and diaries of the study and make available for relatives who can fill the diary study.
History of hypersensitivity to study drugs and rescue;
Any other disease or therapy that in the opinion of the investigator would jeopardize the subject or interfere with the objective of the study;
Subject with a history of ineffectiveness of formoterol fumarate, to fluticasone or salmeterol xinafoate;
Subject who participated in another study within 1 (one) year;
Pregnant women or those with positive serum β-HCG;
Radiological change is not compatible with COPD;
Clinically significant ECG changes, as reported by the investigator;
Any other disease, therapy or laboratory abnormality which in the opinion of the investigator would jeopardize the subject or interfere with the objective of the study;
Use of medications prescribed in the exclusion criteria for visit V -2.
Subjects who had an exacerbation during the standardization that required systemic corticosteroids and / or antibiotics or hospitalization will not be eligible for randomization.
Use of oral corticosteroids, anti-leukotrienes, immunoglobulins (including omalizumab), beta blockers, digitalis, amiodarone, itraconazole, antidepressants, monoamine oxidase inhibitors and tricyclic antidepressants during the period of standardization;
Any other disease or therapy that in the opinion of the investigator would jeopardize the subject or interfere with the objective of the study
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Formoterol/Fluticasone and Salmeterol/Fluticasone in Patients With Moderate-to-severe COPD
We'll reach out to this number within 24 hrs