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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01243788
• Other study ID #: SCO113162
• Secondary ID: SCO113162
• Status: Recruiting
• Phase: Phase 4
• First received: November 18, 2010
• Last updated: November 18, 2010
• Start date: July 2009
• Est. completion date: October 2011

Study information

• Verified date: October 2008
• Source: Fudan University
• Contact: Yutong Y GU, Doctor
• Phone: 8621-64041990
• Email: gu.yutong[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: October 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	West China Hospital of Sichuan	Chendu	Sichuan
China	Chongqing Xinqiao Hospital	Chongqing	Sichuan
China	Gguang Zhou Institute of Respiratory Disease	Guangzhou	Guangdong
China	Affiliated Hospital of Anhui Medical College	Hefei	Anhui
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Zhongshan Hospital	Shanghai	Shanghai
China	Shenyang Military General Hospital	Shenyang	Liaoning
China	Wuxi People's Hospital,	Wuxi	Jiangsu
China	Henan Province Hospital	Zhengzhou	Henan

Sponsors (15)

Lead Sponsor

Collaborator

Fudan University

Armed Police Medical college Affiliated Hospital, Beijing Chao Yang Hospital, Guangzhou First Municipal People’s Hospital, Henan Provincial Hospital, Liaoning Province North Hospital, Peking Union Medical College Hospital, Peking University Third Hospital, Qingdao University, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital with Nanjing Medical University, West China Hospital, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pre-broncholidator FEV1	Change from Baseline in pre-broncholidator FEV1 at 12 weeks	at 12 weeks	No
Secondary	post-broncholidator FEV1	Change from Baseline in post-broncholidator FEV1 at 12 weeks	at 12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes