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

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

Study Contact Backup

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200040

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.

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

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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