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

NCT01243788 | Unknown Phase 4 DMC

• 1 other identifier: SCO113162
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 11

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Seretide; Combivent; effect and safety; Twelve weeks

Outcome Measures

Primary Outcomes (1)

• pre-broncholidator FEV1

  Change from Baseline in pre-broncholidator FEV1 at 12 weeks

  at 12 weeks

Secondary Outcomes (6)

• post-broncholidator FEV1

  at 12 weeks

• 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

• 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

Study Arms (1)

Ipratropium/Albuterol

ACTIVE COMPARATOR

Ipratropium/Albuterol 36/206ug QID

Drug: Salmeterol/Fluticasone Propionate

Interventions

Salmeterol/Fluticasone Propionate DRUG

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

Also known as: Combivent, Salbutamol Aerosol

Ipratropium/Albuterol

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead
• Shanghai Zhongshan Hospital: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Guangzhou First People's Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Peking University Third Hospital: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• West China Hospital: collaborator
• Xinqiao Hospital of Chongqing: collaborator
• Qingdao University: collaborator
• Armed Police Medical college Affiliated Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Henan Provincial People's Hospital: collaborator

Study Sites (11)

Affiliated Hospital of Anhui Medical College

Hefei, Anhui, 230022, China

RECRUITING

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Gguang Zhou Institute of Respiratory Disease

Guangzhou, Guangdong, 510120, China

RECRUITING

Henan Province Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210004, China

RECRUITING

Wuxi People's Hospital,

Wuxi, Jiangsu, 214002, China

RECRUITING

Shenyang Military General Hospital

Shenyang, Liaoning, 110016, China

RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

West China Hospital of Sichuan

Chengdu, Sichuan, 610041, China

RECRUITING

Chongqing Xinqiao Hospital

Chongqing, Sichuan, 430007, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone-Salmeterol Drug Combination; Albuterol, Ipratropium Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Ipratropium; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Chunxue C BAI, Doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yutong Y GU, Doctor

CONTACT

8621-64041990; gu.yutong@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: July 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 19, 2010

Record last verified: 2008-10

Locations

CN (11)