Clinical trial NCT01243788: The Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Atropium/Albuterol in Patients COPD
Official title: Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Ipratropium/Albuterolin Chinese Patients With Moderate-to-severe COPD.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Seretide
Combivent
effect and safety
Twelve weeks
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: The First Affiliated Hospital with Nanjing Medical University
name: Guangzhou First People's Hospital
name: Peking Union Medical College Hospital
name: Beijing Chao Yang Hospital
name: Peking University Third Hospital
name: Liaoning Cancer Hospital & Institute
name: West China Hospital
name: Xinqiao Hospital of Chongqing
name: Qingdao University
name: Armed Police Medical college Affiliated Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Henan Provincial People's Hospital
First posted: 2010-11-19
Enrollment: 450
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: pre-broncholidator FEV1
timeFrame: at 12 weeks
Secondary outcomes:
measure: post-broncholidator FEV1
timeFrame: at 12 weeks
measure: Morning PEF, inspiration capacity (IC) and Residual Volume (RV)
timeFrame: at 12 weeks
measure: Overall daytime symptom score, reliever medication use,SGRQ and BODY index
timeFrame: at 12 weeks
measure: Percent of symptom-free nights, sleep symptoms, nighttime awakenings due to respiratory symptoms
timeFrame: at 12 weeks
measure: Biomarkers: serum Clara cell 16 (CC-16) protein and serum surfactant protein D (SPD)
timeFrame: at 12 weeks
measure: participants with adverse events and COPD exacerbations
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Affiliated Hospital of Anhui Medical College
state: Anhui
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Guangzhou
country: China
facility: Gguang Zhou Institute of Respiratory Disease
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Province Hospital
state: Henan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital,
state: Jiangsu
city: Shenyang
country: China
facility: Shenyang Military General Hospital
state: Liaoning
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Chendu
country: China
facility: West China Hospital of Sichuan
state: Sichuan
city: Chongqing
country: China
facility: Chongqing Xinqiao Hospital
state: Sichuan
Study officials:
affiliation: Fudan University
name: Chunxue C BAI, Doctor
role: PRINCIPAL_INVESTIGATOR
References: