NCT03258749

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

August 13, 2017

Last Update Submit

October 18, 2017

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDGOLDformoteroltiotropium

Outcome Measures

Primary Outcomes (1)

  • postbronchodilator FEV1

    a post-bronchodilator forced expiratory volume in one second

    12 months

Secondary Outcomes (5)

  • the frequency of COPD exacerbation

    12 months

  • other lung function parameters

    12 months

  • CCQ score

    12 months

  • mMRC score

    12 months

  • CAT score

    12 months

Study Arms (2)

Formoterol

ACTIVE COMPARATOR

inhaled formoterol(4.5μg, bid)

Drug: Formoterol

Tiotropium

EXPERIMENTAL

inhaled Tiotropium(18μg, qd)

Drug: Tiotropium

Interventions

TiotropiumDRUG

inhaled Tiotropium(18μg, qd)

Tiotropium
FormoterolDRUG

inhaled formoterol(4.5μg, bid)

Formoterol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of group A or group B stable COPD. Must be able to inhale Formoterol or Tiotropium.

You may not qualify if:

  • Asthma. Cystic fibrosis. Bronchiectasis. Lung cancer. Glaucoma. Tachyarrhythmia or other serious heart diseases. Prostatic hyperplasia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan hospital,Fudan university

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium BromideFormoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingEthanolaminesAmino AlcoholsAlcoholsAmines

Study Officials

  • Shengqing Li, PhD

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengqing Li, PhD

CONTACT

+8602152887072shengqingli@hotmail.com

Peng Zhang, MD

CONTACT

+8602152887073chang0311@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician,Professor

Study Record Dates

First Submitted

August 13, 2017

First Posted

August 23, 2017

Study Start

November 1, 2017

Primary Completion

August 31, 2018

Study Completion

October 31, 2018

Last Updated

October 19, 2017

Record last verified: 2017-10

Locations

CN(1)