Percentage of Annual Acute ExacerbationPhase 4NCT01657487
Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients
A Phase 4 study testing Fluticasone/Salmeterol high dose in people with Percentage of Annual Acute Exacerbation and Quality of Life, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
This study is to investigate and compare treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Percentage of Annual Acute Exacerbation, Quality of Life
- What is being tested?
- Fluticasone/Salmeterol high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2010to Dec 2012
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients aged 40 years≧
- Current or ex-smoker, with smoking history 10 pack≧- years
- COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator)
Who cannot join
- Diagnosis or suspicion of sleep apnea.
- Concurrent rhinitis, eczema, and asthma.
- Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
- A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
- Major disease abnormalities are uncontrolled on therapy.
- Alcohol or medication abuse.
- Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
- Unable or unwilling to comply with all protocol
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
Taipei, 886
Shih-Lung Cheng, MD, PhD, 888-2-89667000 ext. 2816, ntuhwyh61@yahoo.com.tw
Shih-Lung Cheng, MD, PhD
About this study
This study is to investigate and compare treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.
Read the detailed description
Diagnosis and criteria for inclusion and exclusion:
Inclusion:
- Male or female outpatients aged 40 years≧
- Current or ex-smoker, with smoking history 10 pack≧- years
- COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator)
Exclusion:
- Diagnosis or suspicion of sleep apnea.
- Concurrent rhinitis, eczema, and asthma.
- Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
- A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
- Major disease abnormalities are uncontrolled on therapy.
- Alcohol or medication abuse.
- Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
- Unable or unwilling to comply with all protocol
Test product:
fluticasone125 mcg/salmetrol 25 mcg ( Seretide 125 Evohaler ) fluticasone250 mcg/salmetrol 25 mcg ( Seretide 250 Evohaler ) Formulation: fluticasone/salmeterol, 125/25 mcg/puff Dose: 2 puffs bid
- Being tested
- Fluticasone/Salmeterol high dose
- Keywords
- COPD, Fluticasone/Salmeterol, high dose
- 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.
Fluticasone/Salmeterol high doseDrug
Also called COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day)
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone/salmeterol high dose | Experimental | COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day) Receives: Drug: Fluticasone/Salmeterol high dose |
| Fluticasone/Salmeterol medium dose | Active comparator | COPD patients treating with medium dose of ICS (Fluticasone 500ug/day) combined with Salmeterol (25ug/day) Receives: Drug: Fluticasone/Salmeterol high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), before and after treatment.
We will compare the lung function changed in COPD patients treating with different doses of Fluticasone (500 and 1000ug)
Measured: Lung function change in one year
Secondary outcomes (1)
Annual rate of acute exacerbations
- Annual rate of acute exacerbations
- The number of use of rescue medication
- Annual incidence of community-acquired pneumonia
- The changes of Health-related quality of life assessed by questionnaire (CAT or SGRQ) before and after treatment.
Measured: percentage of acute exacerbation in one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startApr 2010
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percentage of Annual Acute ExacerbationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Research Ethics Review Committee
- Responsible party
- Principal investigator, Shih-Lung Cheng, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657487
- Sponsor's protocol ID
- 099013-F
- Status last verified
- Aug 2012
- First submitted
- 2 Aug 2012
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients
- ClinicalTrials.gov ID
- NCT01657487
- Acronym / sponsor ID
- 099013-F
- Keywords
- COPD, Fluticasone/Salmeterol, high dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Collaborators
- Research Ethics Review Committee
- Study start
- Apr 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 6 Aug 2012 (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.
This study is to investigate and compare treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.
Detailed description
Diagnosis and criteria for inclusion and exclusion:
Inclusion:
- Male or female outpatients aged 40 years≧
- Current or ex-smoker, with smoking history 10 pack≧- years
- COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator)
Exclusion:
- Diagnosis or suspicion of sleep apnea.
- Concurrent rhinitis, eczema, and asthma.
- Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
- A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
- Major disease abnormalities are uncontrolled on therapy.
- Alcohol or medication abuse.
- Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
- Unable or unwilling to comply with all protocol
Test product:
fluticasone125 mcg/salmetrol 25 mcg ( Seretide 125 Evohaler ) fluticasone250 mcg/salmetrol 25 mcg ( Seretide 250 Evohaler ) Formulation: fluticasone/salmeterol, 125/25 mcg/puff Dose: 2 puffs bid
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone/salmeterol high dose | Experimental | Drug: Fluticasone/Salmeterol high doseCOPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day) |
| Fluticasone/Salmeterol medium dose | Active comparator | Drug: Fluticasone/Salmeterol high doseCOPD patients treating with medium dose of ICS (Fluticasone 500ug/day) combined with Salmeterol (25ug/day) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female outpatients aged 40 years≧
- Current or ex-smoker, with smoking history 10 pack≧- years
- COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator)
Key exclusion criteria (8 listed)
- Diagnosis or suspicion of sleep apnea.
- Concurrent rhinitis, eczema, and asthma.
- Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
- A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
- Major disease abnormalities are uncontrolled on therapy.
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 |
|---|---|---|
| Fluticasone/Salmeterol high doseAlso: COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day) | Drug | Fluticasone/Salmeterol medium dose, Fluticasone/salmeterol high dose |
Primary outcome
The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), before and after treatment.
Time frame: Lung function change in one year
We will compare the lung function changed in COPD patients treating with different doses of Fluticasone (500 and 1000ug)
1 secondary outcome
Annual rate of acute exacerbations
Time frame: percentage of acute exacerbation in one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone/Salmeterol high dose in people with Percentage of Annual Acute Exacerbation and Quality of Life, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), before and after treatment. (time frame: Lung function change in one year). 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 6 Aug 2012.