Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis

COPD Clinical Trial

Official title:

The Comparisons of the Efficacy and Safety of Inhaled LAMA or LAMA+LABA or ICS+LABA for Patients in COPD C Group With Bronchiectasis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02546297
• Other study ID #: 20150717
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: September 15, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: July 2019
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine which treatment is more effective and safer for the patients in COPD C group with bronchiectasis.The research results will help guide physicians to select appropriate individualized treatment and hopefully provide some evidence-based medicine proofs for revising guide.

Description:

The diagnosis and treatment of COPD and bronchiectasis together seems to be more complicated than the diagnosis and treatment of either condition alone. According to the GOLD，there are three treatments for patients with COPD in group C: ICS combined with LABA or LAMA alone or LABA combined with LAMA. However, it has not yet been demonstrated about which method is more effective for the patients with COPD in group C and bronchiectasis.

This study is designed as a prospective, randomized, case-control trial. Patients are divided into three groups, one group inhaled with ICS and LABA (Symbicort), the second group inhaled with LAMA (Tiotropium Bromide) and the third group inhaled with LAMA(Tiotropium Bromide) and (Symbicort).The course of treatment is 12 months.

The investigators will also assess other relevant outcomes, including the quality of life (QOL) score, pulmonary function test and the incidence of adverse event.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: March 1, 2021
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients are suitable for inclusion in the study when they are 18 years or older diagnosed with COPD C group and bronchiectasis.

Exclusion Criteria:

• active tuberculosis

• severe respiratory disease (such as Lung cancer, ARDS, pulmonary encephalopathy, respiratory failure)

• uncontrollable diabetes

• hypersensitivity to any components of ICS/LABA or LAMA.

Related Conditions & MeSH terms

• Bronchiectasis
• COPD

Intervention

Drug:
• Symbicort
drug are used for 12 months
• Spiriva
drug are used for 12 months

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

References & Publications (3)

Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis. Cochrane Database Syst Rev. 2014 Mar 26;(3):CD010844. doi: 10.1002/14651858.CD010844.pub2. Review. — View Citation

Manoharan A, Short PM, Anderson WJ, Lipworth BJ. Impact of long-acting bronchodilators and exposure to inhaled corticosteroids on mortality in COPD: a real-life retrospective cohort study. Lung. 2014 Oct;192(5):649-52. doi: 10.1007/s00408-014-9611-8. Epub — View Citation

Oba Y, Lone NA. Comparative efficacy of inhaled corticosteroid and long-acting beta agonist combinations in preventing COPD exacerbations: a Bayesian network meta-analysis. Int J Chron Obstruct Pulmon Dis. 2014 May 12;9:469-79. doi: 10.2147/COPD.S48492. e — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute exacerbation	The times of acute exacerbation during the trial.	12 months
Secondary	Number of patients with adverse events	All of the adverse events occurred in the processing of the trial,especially the prevalence of pneumonia.	12 months
Secondary	FEV1	Forced Expiratory Volume in one second	12 months
Secondary	FVC	Forced Vital Capacity	12 months
Secondary	FEV1/FVC	Pulmonary function test	12 months
Secondary	SGRQ	St. George's Respiratory Questionnaire	12 months
Secondary	LCQ	The Leicester Cough Questionnaire	12 months
Secondary	CAT	COPD Assessment Test	12 months
Secondary	mMRC	Modified Medical Research Council Dyspnea Scale	12 months