Comparing Treatment Efficacy With HD/MD Flu Plus Sal in Chronic Obstructive Pulmonary Disease (COPD) Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Taiwan University Hospital
Far Eastern Memorial Hospital
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01131806
First received: May 25, 2010
Last updated: July 7, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: fluticasone/ salmeterol 125/25 mcg/puff
Drug: fluticasone/ salmeterol 250/25 mcg/puff
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • The change of lung function parameters(FEV1&FVC) at different time points [ Time Frame: baseline, week 12, 28 and 52 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Annual rate of acute exacerbations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    total numbers of acute exacerbation throughout the study year

  • Life quality evaluation [ Time Frame: baseline, week 12, 28, and 52 ] [ Designated as safety issue: No ]
    The changes of Health-related quality of life assessed by CAT questionnaire before and after treatment.

  • Annual incidence of community-acquired pneumonia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Annual incidence of community-acquired pneumonia throughout the study year


Estimated Enrollment: 124
Study Start Date: December 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MD Flu/Sal
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.
Drug: fluticasone/ salmeterol 125/25 mcg/puff
fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks
Other Name: Seretide evohaler 125(GlaxoSmithKline)
Experimental: HD Flu/Sal
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.
Drug: fluticasone/ salmeterol 250/25 mcg/puff
fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks
Other Name: Seretide evohaler 250(GlaxoSmithKline)

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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131806

Contacts
Contact: Diahn-Warng Perng, PhD +886-2-28712121 ext 3194 dwperng@vghtpe.gov.tw
Contact: Kang-Cheng Su, MD +886-2-28712121 ext 8928 kcsu@vghtpe.gov.tw

Locations
Taiwan
Chest department, Veteran General Hospital-TAIPEI Recruiting
Taipei City, Taiwan, 112
Contact: Diahn-Warng Perng, PhD    +886-2-28712121 ext 3194    dwperng@vghtpe.gov.tw   
Contact: Kang-Cheng Su, MD    +886-2-28712121 ext 8928    kcsu@vghtpe.gov.tw   
Sub-Investigator: Kang-Cheng Su, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
National Taiwan University Hospital
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Diahn-Warng Perng, PhD Taipei Veterans General Hospital, Taiwan
  More Information

Publications:
Responsible Party: Diahn-Warng PERNG/ Chief, Division of Respiratory Care Unit, Veterans General Hospital-TAIPEI, Department of Chest
ClinicalTrials.gov Identifier: NCT01131806     History of Changes
Other Study ID Numbers: VGHIRB No. 98-10-16, CM981016
Study First Received: May 25, 2010
Last Updated: July 7, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taipei Veterans General Hospital, Taiwan:
chronic obstructive pulmonary disease
lung function change FEV1 FVC
acute exacerbation
life quality questionnaire

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone
Salmeterol
Albuterol
Fluticasone, salmeterol drug combination
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014