The Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Atropium/Albuterol in Patients COPD
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Salmeterol/Fluticasone Propionate
- Registration Number
- NCT01243788
- Lead Sponsor
- Fudan University
- Brief Summary
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
* 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.
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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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 450
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ipratropium/Albuterol Salmeterol/Fluticasone Propionate Ipratropium/Albuterol 36/206ug QID
- Primary Outcome Measures
Name Time Method pre-broncholidator FEV1 at 12 weeks Change from Baseline in pre-broncholidator FEV1 at 12 weeks
- Secondary Outcome Measures
Name Time Method post-broncholidator FEV1 at 12 weeks Change from Baseline in post-broncholidator FEV1 at 12 weeks
Morning PEF, inspiration capacity (IC) and Residual Volume (RV) 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 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 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) 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 at 12 weeks Change from Baseline in number of participants with adverse events and COPD exacerbations at 12 weeks
Trial Locations
- Locations (11)
Henan Province Hospital
🇨🇳Zhengzhou, Henan, China
Affiliated Hospital of Anhui Medical College
🇨🇳Hefei, Anhui, China
Beijing Chaoyang Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Gguang Zhou Institute of Respiratory Disease
🇨🇳Guangzhou, Guangdong, China
Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
Shenyang Military General Hospital
🇨🇳Shenyang, Liaoning, China
Wuxi People's Hospital,
🇨🇳Wuxi, Jiangsu, China
West China Hospital of Sichuan
🇨🇳Chendu, Sichuan, China
Chongqing Xinqiao Hospital
🇨🇳Chongqing, Sichuan, China