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

Study Overview
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Brief Summary
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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).

Detailed Description
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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. If satisfying the entry criteria, patients enter an 8 to 14 day run-in period,and replace previous bronchodilators with inhaled or nebulized Salbutamol. 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. 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. 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. Eligible patients will be randomized (1:1) to the following 2 treatments for 12 weeks. Inhaled Salmeterol/Fluticasone propionate 50/500ug twice daily or inhaled IB/ALB 36/206ug QID. Salbutamol will be provided for relief of symptoms on an as required basis during the whole 12 weeks. 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.

Official Title
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Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Ipratropium/Albuterolin Chinese Patients With Moderate-to-severe COPD.

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Salmeterol/Fluticasone Propionate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ipratropium/Albuterol<br>Ipratropium/Albuterol 36/206ug QID | Drug: Salmeterol/Fluticasone Propionate<br>* Salmeterol/Fluticasone 50/500ug twice daily Duration:12 weeks<br>* Other names: Salbutamol Aerosol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-broncholidator FEV1 | Change from Baseline in pre-broncholidator FEV1 at 12 weeks | at 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Seretide, Combivent, effect and safety, Twelve weeks