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

NCT03258749 — Not applicable, Unknown, 120 participants, Huashan Hospital

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Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD: a Randomised, Open-label, Multicentre Trial

RegistryNCT03258749, acronym FACT
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment120 (Estimated)
SponsorHuashan Hospital (Other)
ConditionsChronic Obstructive Pulmonary Disease
InterventionsTiotropium, Formoterol (Drug)
Datesstart 2017-11-01 (estimated), primary completion 2018-08-31 (estimated), completion 2018-10-31 (estimated), first posted 2017-08-23, last updated 2017-10-19
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Obstructive Pulmonary Disease All trials of Tiotropium All trials of Formoterol

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
FormoterolActive comparatorDrug: Formoterolinhaled formoterol(4.5μg, bid)
TiotropiumExperimentalDrug: Tiotropiuminhaled Tiotropium(18μg, qd)
  • Tiotropium (Drug): inhaled Tiotropium(18μg, qd)
  • Formoterol (Drug): inhaled formoterol(4.5μg, bid)

+Outcome measures

Primary outcomes

  • postbronchodilator FEV1 [12 months]: a post-bronchodilator forced expiratory volume in one second

Secondary outcomes

  • the frequency of COPD exacerbation [12 months]: the frequency of COPD exacerbation
  • other lung function parameters [12 months]: other lung function parameters(%FEV1, FEV1/FVC)
  • CCQ score [12 months]: Clinical COPD Questionnaire score
  • mMRC score [12 months]: modified Medical Research Council score
  • CAT score [12 months]: COPD Assessment Test score

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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.

+Locations (1)

FacilityCityCountryStatus
Huashan hospital,Fudan universityShanghai, Shanghai MunicipalityChina

+Investigators