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

• Status: Unknown status
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: Armed Police Medical college Affiliated Hospital; Beijing Chao Yang Hospital; Guangzhou First Municipal People’s Hospital; Guangzhou First People's Hospital; Henan Provincial Hospital; Henan Provincial People's Hospital; Liaoning Province North Hospital; Liaoning Tumor Hospital & Institute; 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
• Treatments: Albuterol; Fluticasone; Ipratropium; Salmeterol Xinafoate; Xhance

Criteria

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