Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD (FACT)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tiotropium
Formoterol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, GOLD, formoterol, tiotropium
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of group A or group B stable COPD. Must be able to inhale Formoterol or Tiotropium.
Exclusion Criteria:
Asthma. Cystic fibrosis. Bronchiectasis. Lung cancer. Glaucoma. Tachyarrhythmia or other serious heart diseases. Prostatic hyperplasia.
Sites / Locations
- Huashan hospital,Fudan university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Formoterol
Tiotropium
Arm Description
inhaled formoterol(4.5μg, bid)
inhaled Tiotropium(18μg, qd)
Outcomes
Primary Outcome Measures
postbronchodilator FEV1
a post-bronchodilator forced expiratory volume in one second
Secondary Outcome Measures
the frequency of COPD exacerbation
the frequency of COPD exacerbation
other lung function parameters
other lung function parameters(%FEV1, FEV1/FVC)
CCQ score
Clinical COPD Questionnaire score
mMRC score
modified Medical Research Council score
CAT score
COPD Assessment Test score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03258749
Brief Title
Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD
Acronym
FACT
Official Title
Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD: a Randomised, Open-label, Multicentre Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Anticipated)
Primary Completion Date
August 31, 2018 (Anticipated)
Study Completion Date
October 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic obstructive pulmonary disease (COPD) is a disease state characterized by persistent airflow limitation and associated with an accelerated decline in lung function, impaired quality of life, hospitalization, and increased mortality. As a major public health problem, COPD is predicted to rank as the fifth burden of diseases in the world by 2020. Thus, prevention of exacerbations is a important goal in the management of COPD. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) Scientific Committee launched a joint project in 1998. Its goals were to raise awareness of COPD and to improve prevention and treatment of COPD patients around the world. In the 2017 GOLD guidelines, inhaled long-acting bronchodilators, including inhaled long-acting muscarinic antagonists (LAMAs) and inhaled long-acting beta-agonists (LABAs), are recommended for the management of all stable COPD patients. However, it is not known whether LABA or LAMA will be more effective for initial relief of symptoms in patients with GOLD A/B COPD. In this multicenter, randomized study, the investigators evaluate the efficacy of formoterol(LABA) and tiotropium(LAMA) in the treatment of patients with GOLD A/B COPD. The primary endpoint is postbronchodilator FEV1, and the secondary endpoints include the frequency of COPD exacerbation, other lung function parameters, CCQ score and mMRC/CAT score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, GOLD, formoterol, tiotropium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Formoterol
Arm Type
Active Comparator
Arm Description
inhaled formoterol(4.5μg, bid)
Arm Title
Tiotropium
Arm Type
Experimental
Arm Description
inhaled Tiotropium(18μg, qd)
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Description
inhaled Tiotropium(18μg, qd)
Intervention Type
Drug
Intervention Name(s)
Formoterol
Intervention Description
inhaled formoterol(4.5μg, bid)
Primary Outcome Measure Information:
Title
postbronchodilator FEV1
Description
a post-bronchodilator forced expiratory volume in one second
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the frequency of COPD exacerbation
Description
the frequency of COPD exacerbation
Time Frame
12 months
Title
other lung function parameters
Description
other lung function parameters(%FEV1, FEV1/FVC)
Time Frame
12 months
Title
CCQ score
Description
Clinical COPD Questionnaire score
Time Frame
12 months
Title
mMRC score
Description
modified Medical Research Council score
Time Frame
12 months
Title
CAT score
Description
COPD Assessment Test score
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of group A or group B stable COPD. Must be able to inhale Formoterol or Tiotropium.
Exclusion Criteria:
Asthma. Cystic fibrosis. Bronchiectasis. Lung cancer. Glaucoma. Tachyarrhythmia or other serious heart diseases. Prostatic hyperplasia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengqing Li, PhD
Phone
+8602152887072
Email
shengqingli@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Zhang, MD
Phone
+8602152887073
Email
chang0311@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengqing Li, PhD
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan hospital,Fudan university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengqing Li, PhD
Phone
+8602152887072
Email
shengqingli@hotmail.com
First Name & Middle Initial & Last Name & Degree
Peng Zhang, MD
Phone
+8602152887073
Email
chang0311@foxmail.com
12. IPD Sharing Statement
Learn more about this trial
Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD
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