Chronic Obstructive Pulmonary DiseasePhase 4NCT01131806
Comparing Treatment Efficacy With HD/MD Flu Plus Sal in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 4 study testing fluticasone/ salmeterol 125/25 mcg/puff and fluticasone/ salmeterol 250/25 mcg/puff in people with Chronic Obstructive Pulmonary Disease, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Chronic obstructive pulmonary disease is characterized as inflammatory airway with not fully reversible airflow limitation.Combination treatment with inhaled corticosteroid (ICS) and long-acting β2 agonists (LABA)attains an improved control of symptoms and lung function, that are superior to those associated with… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- fluticasone/ salmeterol 125/25 mcg/puff and fluticasone/ salmeterol 250/25 mcg/puff
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2009to Apr 2011
- 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 90 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 specified procedures.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chest department, Veteran General Hospital-TAIPEI
Taipei, Taiwan, 112
Diahn-Warng Perng, PhD, +886-2-28712121 ext. 3194, dwperng@vghtpe.gov.tw
Kang-Cheng Su, MD, +886-2-28712121 ext. 8928, kcsu@vghtpe.gov.tw
About this study
Official title: Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients
Chronic obstructive pulmonary disease is characterized as inflammatory airway with not fully reversible airflow limitation.Combination treatment with inhaled corticosteroid (ICS) and long-acting β2 agonists (LABA)attains an improved control of symptoms and lung function, that are superior to those associated with either drug alone. However, the treatment efficacy between high and medium dose of inhaled corticosteroid in combination of LABA is still unknown. The aim of the current study is to investigate the treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and the use of health care resources worldwide. It is characterized by chronic progressive symptoms, airflow obstruction, and impaired health status, which is worse in those who have frequent, acute episodes of symptom exacerbation. Treatment for COPD is focused on minimizing risk factors, improving symptoms, and preventing exacerbations.
Pulmonary inflammation is the key factor in COPD. Inhaled long-acting β2 agonists (LABA) improve airflow obstruction, control of symptoms, and health status in patients with COPD over 3 to 4 months. Inhaled corticosteroids (ICS) are currently the most popular anti-inflammatory medications for use in symptomatic patients with COPD. Previous large scaled randomized control study discovered long-term use of ICS didn't modified annual decline of lung function in COPD patients, but may reduce the frequency of exacerbations, especially when combined with an LABA.
Combination treatment with ICS and LABA has been widely used for patients with COPD and attains an improved control of symptoms and lung function, with no greater risk of side-effects than that of treatment with either component alone. Combined ICS/LABA will result in better treatment effects that are superior to those associated with either drug alone. However, the treatment efficacy between high and medium dose of inhaled corticosteroid in combination of LABA is still unknown. The aim of the current study is to investigate the treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- fluticasone/ salmeterol 125/25 mcg/puff, fluticasone/ salmeterol 250/25 mcg/puff
- Keywords
- chronic obstructive pulmonary disease, lung function change FEV1 FVC, acute exacerbation, life quality questionnaire
- 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 125/25 mcg/puffDrug
Also called Seretide evohaler 125(GlaxoSmithKline)
fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks
fluticasone/ salmeterol 250/25 mcg/puffDrug
Also called Seretide evohaler 250(GlaxoSmithKline)
fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| MD Flu/Sal | Active comparator | fluticasone125 mcg/ salmeterol 25 mcg 2puffs (medium dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis. Receives: Drug: fluticasone/ salmeterol 125/25 mcg/puff |
| HD Flu/Sal | Experimental | fluticasone 250 mcg/salmeterol 25 mcg 2puffs (high dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis. Receives: Drug: fluticasone/ salmeterol 250/25 mcg/puff |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of lung function parameters(FEV1&FVC) at different time points
The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), at different time points, including baseline, 12th week, 28th week, and ending (52th week).
Measured: baseline, week 12, 28 and 52
Secondary outcomes (3)
Annual rate of acute exacerbations
total numbers of acute exacerbation throughout the study year
Measured: 1 year
Life quality evaluation
The changes of Health-related quality of life assessed by CAT questionnaire before and after treatment.
Measured: baseline, week 12, 28, and 52
Annual incidence of community-acquired pneumonia
Annual incidence of community-acquired pneumonia throughout the study year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startDec 2009
- Primary completionNov 2010 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Taiwan University Hospital, Far Eastern Memorial Hospital
- Investigators
- Diahn-Warng Perng, PhD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131806
- Sponsor's protocol ID
- VGHIRB No. 98-10-16
- Other IDs
- CM981016
- Status last verified
- Jan 2010
- First submitted
- 25 May 2010
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J; TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007 Feb 22;356(8):775-89. doi: 10.1056/NEJMoa063070.
PubMed 17314337Keating GM, McCormack PL. Salmeterol/fluticasone propionate: a review of its use in the treatment of chronic obstructive pulmonary disease. Drugs. 2007;67(16):2383-405. doi: 10.2165/00003495-200767160-00006.
PubMed 17983257Hanania NA, Darken P, Horstman D, Reisner C, Lee B, Davis S, Shah T. The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD. Chest. 2003 Sep;124(3):834-43. doi: 10.1378/chest.124.3.834.
PubMed 12970006Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R, Nahabedian S, Peterson S, Olsson H. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J. 2003 Jan;21(1):74-81. doi: 10.1183/09031936.03.00031402.
PubMed 12570112
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. 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
- NCT01131806
- Acronym / sponsor ID
- VGHIRB No. 98-10-16
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, lung function change FEV1 FVC, acute exacerbation, life quality questionnaire
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- National Taiwan University Hospital, Far Eastern Memorial Hospital
- Study start
- Dec 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 27 May 2010 (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.
Chronic obstructive pulmonary disease is characterized as inflammatory airway with not fully reversible airflow limitation.Combination treatment with inhaled corticosteroid (ICS) and long-acting β2 agonists (LABA)attains an improved control of symptoms and lung function, that are superior to those associated with either drug alone. However, the treatment efficacy between high and medium dose of inhaled corticosteroid in combination of LABA is still unknown. The aim of the current study is to investigate the treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and the use of health care resources worldwide. It is characterized by chronic progressive symptoms, airflow obstruction, and impaired health status, which is worse in those who have frequent, acute episodes of symptom exacerbation. Treatment for COPD is focused on minimizing risk factors, improving symptoms, and preventing exacerbations.
Pulmonary inflammation is the key factor in COPD. Inhaled long-acting β2 agonists (LABA) improve airflow obstruction, control of symptoms, and health status in patients with COPD over 3 to 4 months. Inhaled corticosteroids (ICS) are currently the most popular anti-inflammatory medications for use in symptomatic patients with COPD. Previous large scaled randomized control study discovered long-term use of ICS didn't modified annual decline of lung function in COPD patients, but may reduce the frequency of exacerbations, especially when combined with an LABA.
Combination treatment with ICS and LABA has been widely used for patients with COPD and attains an improved control of symptoms and lung function, with no greater risk of side-effects than that of treatment with either component alone. Combined ICS/LABA will result in better treatment effects that are superior to those associated with either drug alone. However, the treatment efficacy between high and medium dose of inhaled corticosteroid in combination of LABA is still unknown. The aim of the current study is to investigate the treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MD Flu/Sal | Active comparator | Drug: fluticasone/ salmeterol 125/25 mcg/pufffluticasone125 mcg/ salmeterol 25 mcg 2puffs (medium dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis. |
| HD Flu/Sal | Experimental | Drug: fluticasone/ salmeterol 250/25 mcg/pufffluticasone 250 mcg/salmeterol 25 mcg 2puffs (high dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis. |
Who may qualify
- Ages
- 40 to 90 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 125/25 mcg/puffAlso: Seretide evohaler 125(GlaxoSmithKline)fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks | Drug | MD Flu/Sal |
| fluticasone/ salmeterol 250/25 mcg/puffAlso: Seretide evohaler 250(GlaxoSmithKline)fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks | Drug | HD Flu/Sal |
Primary outcome
The change of lung function parameters(FEV1&FVC) at different time points
Time frame: baseline, week 12, 28 and 52
The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), at different time points, including baseline, 12th week, 28th week, and ending (52th week).
3 secondary outcomes
Annual rate of acute exacerbations
Time frame: 1 year
Life quality evaluation
Time frame: baseline, week 12, 28, and 52
Annual incidence of community-acquired pneumonia
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2010.
- Background: PubMed 17314337Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J; TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007 Feb 22;356(8):775-89. doi: 10.1056/NEJMoa063070.
- Background: PubMed 17983257Keating GM, McCormack PL. Salmeterol/fluticasone propionate: a review of its use in the treatment of chronic obstructive pulmonary disease. Drugs. 2007;67(16):2383-405. doi: 10.2165/00003495-200767160-00006.
- Background: PubMed 12970006Hanania NA, Darken P, Horstman D, Reisner C, Lee B, Davis S, Shah T. The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD. Chest. 2003 Sep;124(3):834-43. doi: 10.1378/chest.124.3.834.
- Background: PubMed 12570112Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R, Nahabedian S, Peterson S, Olsson H. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J. 2003 Jan;21(1):74-81. doi: 10.1183/09031936.03.00031402.
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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.
Diahn-Warng Perng, PhD principal investigator
Taipei Veterans General Hospital, Taiwan
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 125/25 mcg/puff and fluticasone/ salmeterol 250/25 mcg/puff in people with Chronic Obstructive Pulmonary Disease, run by Taipei Veterans General Hospital, Taiwan 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 8 Jul 2010. 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?
Contact Diahn-Warng Perng, PhD (+886-2-28712121 ext. 3194, dwperng@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of lung function parameters(FEV1&FVC) at different time points (time frame: baseline, week 12, 28 and 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01131806, which also lists 4 linked publications.
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 8 Jul 2010.