Comparing Treatment Efficacy With HD/MD Flu Plus Sal in Chronic Obstructive Pulmonary Disease (COPD) Patients
2 other identifiers
interventional
124
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 chronic-obstructive-pulmonary-disease
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJuly 8, 2010
January 1, 2010
11 months
May 25, 2010
July 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
baseline, week 12, 28 and 52
Secondary Outcomes (3)
Annual rate of acute exacerbations
1 year
Life quality evaluation
baseline, week 12, 28, and 52
Annual incidence of community-acquired pneumonia
1 year
Study Arms (2)
MD Flu/Sal
ACTIVE COMPARATORfluticasone125 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
EXPERIMENTALfluticasone 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.
Interventions
fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks
fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taipei Veterans General Hospital, Taiwanlead
- National Taiwan University Hospitalcollaborator
- Far Eastern Memorial Hospitalcollaborator
Study Sites (1)
Chest department, Veteran General Hospital-TAIPEI
Taipei, Taiwan, 112, Taiwan
Related Publications (4)
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.
PMID: 17314337BACKGROUNDKeating 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.
PMID: 17983257BACKGROUNDHanania 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.
PMID: 12970006BACKGROUNDSzafranski 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.
PMID: 12570112BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diahn-Warng Perng, PhD
Taipei Veterans General Hospital, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
May 25, 2010
First Posted
May 27, 2010
Study Start
December 1, 2009
Primary Completion
November 1, 2010
Study Completion
April 1, 2011
Last Updated
July 8, 2010
Record last verified: 2010-01