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Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD (FACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03258749
Recruitment Status : Unknown
Verified October 2017 by Shengqing Li, Huashan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 23, 2017
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):
Shengqing Li, Huashan Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Tiotropium Drug: Formoterol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD: a Randomised, Open-label, Multicentre Trial
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Formoterol
inhaled formoterol(4.5μg, bid)
Drug: Formoterol
inhaled formoterol(4.5μg, bid)

Experimental: Tiotropium
inhaled Tiotropium(18μg, qd)
Drug: Tiotropium
inhaled Tiotropium(18μg, qd)

Primary Outcome Measures :
  1. postbronchodilator FEV1 [ Time Frame: 12 months ]
    a post-bronchodilator forced expiratory volume in one second

Secondary Outcome Measures :
  1. the frequency of COPD exacerbation [ Time Frame: 12 months ]
    the frequency of COPD exacerbation

  2. other lung function parameters [ Time Frame: 12 months ]
    other lung function parameters(%FEV1, FEV1/FVC)

  3. CCQ score [ Time Frame: 12 months ]
    Clinical COPD Questionnaire score

  4. mMRC score [ Time Frame: 12 months ]
    modified Medical Research Council score

  5. CAT score [ Time Frame: 12 months ]
    COPD Assessment Test score

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03258749

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Contact: Shengqing Li, PhD +8602152887072
Contact: Peng Zhang, MD +8602152887073

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China, Shanghai
Huashan hospital,Fudan university
Shanghai, Shanghai, China, 200040
Contact: Shengqing Li, PhD    +8602152887072   
Contact: Peng Zhang, MD    +8602152887073   
Sponsors and Collaborators
Huashan Hospital
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Principal Investigator: Shengqing Li, PhD Huashan Hospital
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Responsible Party: Shengqing Li, Chief Physician,Professor, Huashan Hospital Identifier: NCT03258749    
Other Study ID Numbers: KY2017-009
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017

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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
Keywords provided by Shengqing Li, Huashan Hospital:
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Formoterol Fumarate
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents