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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
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, GOLD, formoterol, tiotropium

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 13, 2017
Last Updated
October 18, 2017
Sponsor
Huashan Hospital
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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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