The Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Atropium/Albuterol in Patients COPD

Overview

To determine the efficacy and safety of Salmeterol/Fluticasone Propionate 50/500ug BID vs Ipratropium/Albuterol 36/206ug QID in Chinese patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).

Full Title of Study: “Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Ipratropium/Albuterolin Chinese Patients With Moderate-to-severe COPD.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2011

Detailed Description

- This is a 12-week, multicentre,randomized,open-label,active-controlled, paralleled-group study.

- Chinese patients aged ≥40 years with moderate-to-severe COPD are eligible for this study.

1. If satisfying the entry criteria, patients enter an 8 to 14 day run-in period,and replace previous bronchodilators with inhaled or nebulized Salbutamol.

2. Patients record daily severity ratings for daytime symptoms of shortness of breath, tiredness, activity limitation, frustration with symptoms, and night-time sleep symptoms on daily cards.

3. Each symptom is rated using 0-100 visual analog scal (VAS). For overall assessment of daytime symptoms, a combined symptom score is obtained by adding VAS scores for shortness of breath, tiredness, activity limitation, frustration with symptoms.

4. Patients are required to be symptomatic as demonstrated by a combined daytime symptom score of 120 on at least 4 of the 7 days prior to randomization.

1. Eligible patients will be randomized (1:1) to the following 2 treatments for 12 weeks.

1. Inhaled Salmeterol/Fluticasone propionate 50/500ug twice daily or inhaled IB/ALB 36/206ug QID.

2. Salbutamol will be provided for relief of symptoms on an "as required" basis during the whole 12 weeks.

2. A Follow-up visit will be conducted 2 weeks after completion of treatment/early withdrawal to assess for any adverse effects after discontinuing study treatment.

Interventions

  • Drug: Salmeterol/Fluticasone Propionate
    • Salmeterol/Fluticasone 50/500ug twice daily Duration:12 weeks

Arms, Groups and Cohorts

  • Active Comparator: Ipratropium/Albuterol
    • Ipratropium/Albuterol 36/206ug QID

Clinical Trial Outcome Measures

Primary Measures

  • pre-broncholidator FEV1
    • Time Frame: at 12 weeks
    • Change from Baseline in pre-broncholidator FEV1 at 12 weeks

Secondary Measures

  • post-broncholidator FEV1
    • Time Frame: at 12 weeks
    • Change from Baseline in post-broncholidator FEV1 at 12 weeks
  • Morning PEF, inspiration capacity (IC) and Residual Volume (RV)
    • Time Frame: at 12 weeks
    • Change from Baseline in morning PEF, inspiration capacity (IC) and Residual Volume (RV)at 12 weeks
  • Overall daytime symptom score, reliever medication use,SGRQ and BODY index
    • Time Frame: at 12 weeks
    • Change from Baseline in overall daytime symptom score, reliever medication use,SGRQ and BODY index at 12 weeks
  • Percent of symptom-free nights, sleep symptoms, nighttime awakenings due to respiratory symptoms
    • Time Frame: at 12 weeks
    • Change from Baseline in percent of symptom-free nights, sleep symptoms, nighttime awakenings due to respiratory symptoms at 12 weeks
  • Biomarkers: serum Clara cell 16 (CC-16) protein and serum surfactant protein D (SPD)
    • Time Frame: at 12 weeks
    • Change from Baseline in biomarkers: serum Clara cell 16 (CC-16) protein and serum surfactant protein D (SPD) at 12 weeks
  • participants with adverse events and COPD exacerbations
    • Time Frame: at 12 weeks
    • Change from Baseline in number of participants with adverse events and COPD exacerbations at 12 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Chinese male or female outpatients aged 40 to 79 years, inclusive
  • Patients with an established diagnosis of COPD, defined as GOLD guideline postbronchodilation FEV1/FVC ratio of <70%, AND Postbronchodilation FEV1% predicted ranged from ≥25 to ≤70.
  • A cigarette smoking history of 10 pack-years
  • Use of oral theophylline, or any other inhaled medications other than LABA, LAMA, or ICS for≥30 days (e.g. SABA, SAMA)
  • Patients who are able to use Accuhaler device and relief medication
  • Patients willing to give informed consent to participate in the study and comply to study protocol
  • Eligible female on child-bearing potentia

Exclusion Criteria

  • Patients with concurrent respiratory disorders (e.g. asthma) other than COPD
  • Patients with a requirement for regular or long term oxygen therapy (>12h/d)
  • Patients who used inhaled or oral steroids within 30 days of screening
  • Patients who had a respiratory tract infection requiring antibiotics within 14 days of screening
  • Patients with a moderate-to-severe COPD exacerbation within 30 days of screening
  • Patients with any significant medical condition or disease that would place patients at risk or interfere with the study evaluation.
  • Patients who used some inhibitory agents (e.g. b blockers) within 14 days of screening
  • Female patients who is pregnant or may be pregnant in the study duration

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Collaborator
    • Shanghai Zhongshan Hospital
  • Provider of Information About this Clinical Study
    • Chunxue BAI, Zhongshan Hospital
  • Overall Official(s)
    • Chunxue C BAI, Doctor, Principal Investigator, Fudan University
  • Overall Contact(s)
    • Yutong Y GU, Doctor, 8621-64041990, gu.yutong@zs-hospital.sh.cn

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