CClinicalTrials.gg
Status unknownNCT03258749FACTUpdated Oct 19, 2017

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

An interventional study of Tiotropium and Formoterol in Chronic Obstructive Pulmonary Disease, sponsored by Huashan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-19.

Sponsored by Huashan Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • GOLD
  • formoterol
  • tiotropium
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

Exclusion Criteria:

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

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Formoterol

    inhaled formoterol(4.5μg, bid)

    Drug: Formoterol

  • Experimental
    Tiotropium

    inhaled Tiotropium(18μg, qd)

    Drug: Tiotropium

Interventions

  • DrugTiotropium

    inhaled Tiotropium(18μg, qd)

  • DrugFormoterol

    inhaled formoterol(4.5μg, bid)

05

What researchers measure

Primary outcomes

  1. postbronchodilator FEV1

    a post-bronchodilator forced expiratory volume in one second

    Time frame: 12 months

Secondary outcomes

  1. the frequency of COPD exacerbation

    the frequency of COPD exacerbation

    Time frame: 12 months

  2. other lung function parameters

    other lung function parameters(%FEV1, FEV1/FVC)

    Time frame: 12 months

  3. CCQ score

    Clinical COPD Questionnaire score

    Time frame: 12 months

  4. mMRC score

    modified Medical Research Council score

    Time frame: 12 months

  5. CAT score

    COPD Assessment Test score

    Time frame: 12 months

06

Study locations

1 site
07

Registry details

Key details

Study ID
NCT03258749
Lead sponsor
Huashan Hospital
Responsible party
Shengqing Li (Chief Physician,Professor, Huashan Hospital) — Principal investigator
First posted
Aug 23, 2017
Start date
Nov 1, 2017 (estimated)
Primary completion
Aug 31, 2018 (estimated)
Completion
Oct 31, 2018 (estimated)
Last update
Oct 19, 2017

Study contacts

Shengqing Li, PhD
Contact
shengqingli@hotmail.com
+8602152887072
Peng Zhang, MD
Contact
chang0311@foxmail.com
+8602152887073
Shengqing Li, PhD
principal investigator · Huashan Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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