Chronic Obstructive Pulmonary DiseasePhase 3NCT01393145
Efficacy and Safety Study of Formoterol/Fluticasone and Salmeterol/Fluticasone in Patients With Moderate-to-severe COPD
A Phase 3 study testing Combination Fluticasone /Formoterol 12/250 μg and Seretide Diskus (salmeterol/fluticasone) 50/250 μg in people with Chronic Obstructive Pulmonary Disease and COPD, run by Ache Laboratorios Farmaceuticos S.A..
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- Combination Fluticasone /Formoterol 12/250 μg and Seretide Diskus (salmeterol/fluticasone) 50/250 μg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Aug 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
About this study
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).
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
- Being tested
- Combination Fluticasone /Formoterol 12/250 μg, Seretide Diskus (salmeterol/fluticasone) 50/250 μg
- Keywords
- Chronic obstructive pulmonary disease (COPD), salmeterol, fluticasone, formoterol, FEV1, Moderate-to-severe
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination Fluticasone /Formoterol 12/250 μgDrug
Capsules containing Fumarate formoterol 12 µg + fluticasone propionate 250 µg dry powder for inhalation with aerocaps®
Seretide Diskus (salmeterol/fluticasone) 50/250 μgDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Drug: Combination Fluticasone /Formoterol 12/250 μg |
| Group 2 | Active comparator | Not described Receives: Drug: Seretide Diskus (salmeterol/fluticasone) 50/250 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pre-bronchodilator forced expiratory volume in first second (FEV1)
Changes of lung function parameter
Measured: Comparative between baseline and week 24
Secondary outcomes (3)
Changes in forced expiratory volume in first second, without bronchodilator
Changes of lung function parameter
Measured: Week 0, 8, 16 and 24
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
Measured: From baseline to week 24
Changes in COPD Assessment Test (CAT)
Questionnaire
Measured: Week 0, 8, 16 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393145
- Sponsor's protocol ID
- ACH-LLN-03(06/10)
- Status last verified
- Feb 2017
- First submitted
- 9 Mar 2011
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT01393145
- Acronym / sponsor ID
- ACH-LLN-03(06/10)
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Keywords
- Chronic obstructive pulmonary disease (COPD), salmeterol, fluticasone, formoterol, FEV1, Moderate-to-severe
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Combination Fluticasone /Formoterol 12/250 μg |
| Group 2 | Active comparator | Drug: Seretide Diskus (salmeterol/fluticasone) 50/250 μg |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (28 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination Fluticasone /Formoterol 12/250 μgCapsules containing Fumarate formoterol 12 µg + fluticasone propionate 250 µg dry powder for inhalation with aerocaps® | Drug | Group 1 |
| Seretide Diskus (salmeterol/fluticasone) 50/250 μgCapsules 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 | Drug | Group 2 |
Primary outcome
Changes in pre-bronchodilator forced expiratory volume in first second (FEV1)
Time frame: Comparative between baseline and week 24
Changes of lung function parameter
3 secondary outcomes
Changes in forced expiratory volume in first second, without bronchodilator
Time frame: Week 0, 8, 16 and 24
Safety descriptive about occurence of adverse events, evaluation of results of clinical/physical examination and laboratory tests results
Time frame: From baseline to week 24
Changes in COPD Assessment Test (CAT)
Time frame: Week 0, 8, 16 and 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combination Fluticasone /Formoterol 12/250 μg and Seretide Diskus (salmeterol/fluticasone) 50/250 μg in people with Chronic Obstructive Pulmonary Disease and COPD, run by Ache Laboratorios Farmaceuticos S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pre-bronchodilator forced expiratory volume in first second (FEV1) (time frame: Comparative between baseline and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.