- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03258749
Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD (FACT)
October 18, 2017 updated by: Shengqing Li, Huashan Hospital
Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD: a Randomised, Open-label, Multicentre Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shengqing Li, PhD
- Phone Number: +8602152887072
- Email: shengqingli@hotmail.com
Study Contact Backup
- Name: Peng Zhang, MD
- Phone Number: +8602152887073
- Email: chang0311@foxmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200040
- Huashan Hospital,Fudan University
-
Contact:
- Shengqing Li, PhD
- Phone Number: +8602152887072
- Email: shengqingli@hotmail.com
-
Contact:
- Peng Zhang, MD
- Phone Number: +8602152887073
- Email: chang0311@foxmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Formoterol
inhaled formoterol(4.5μg, bid)
|
inhaled formoterol(4.5μg, bid)
|
Experimental: Tiotropium
inhaled Tiotropium(18μg, qd)
|
inhaled Tiotropium(18μg, qd)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postbronchodilator FEV1
Time Frame: 12 months
|
a post-bronchodilator forced expiratory volume in one second
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
other lung function parameters
Time Frame: 12 months
|
other lung function parameters(%FEV1, FEV1/FVC)
|
12 months
|
CCQ score
Time Frame: 12 months
|
Clinical COPD Questionnaire score
|
12 months
|
mMRC score
Time Frame: 12 months
|
modified Medical Research Council score
|
12 months
|
CAT score
Time Frame: 12 months
|
COPD Assessment Test score
|
12 months
|
the frequency of COPD exacerbation
Time Frame: 12 months
|
the frequency of COPD exacerbation
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shengqing Li, PhD, Huashan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2017
Primary Completion (Anticipated)
August 31, 2018
Study Completion (Anticipated)
October 31, 2018
Study Registration Dates
First Submitted
August 13, 2017
First Submitted That Met QC Criteria
August 22, 2017
First Posted (Actual)
August 23, 2017
Study Record Updates
Last Update Posted (Actual)
October 19, 2017
Last Update Submitted That Met QC Criteria
October 18, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tiotropium Bromide
- Formoterol Fumarate
Other Study ID Numbers
- KY2017-009
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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