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

NCT ID: NCT03258749

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD GOLD formoterol tiotropium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Formoterol

inhaled formoterol(4.5μg, bid)

Group Type ACTIVE_COMPARATOR

Formoterol

Intervention Type DRUG

inhaled formoterol(4.5μg, bid)

Tiotropium

inhaled Tiotropium(18μg, qd)

Group Type EXPERIMENTAL

Tiotropium

Intervention Type DRUG

inhaled Tiotropium(18μg, qd)

Interventions

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Tiotropium

inhaled Tiotropium(18μg, qd)

Intervention Type DRUG

Formoterol

inhaled formoterol(4.5μg, bid)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shengqing Li

Chief Physician,Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shengqing Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

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Huashan hospital,Fudan university

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Shengqing Li, PhD

Role: CONTACT

Phone: +8602152887072

Email: [email protected]

Peng Zhang, MD

Role: CONTACT

Phone: +8602152887073

Email: [email protected]

Facility Contacts

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Shengqing Li, PhD

Role: primary

Peng Zhang, MD

Role: backup

Other Identifiers

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KY2017-009

Identifier Type: -

Identifier Source: org_study_id