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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02546297
Recruitment Status : Enrolling by invitation
First Posted : September 10, 2015
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

Brief 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.

Condition or disease Intervention/treatment Phase
COPD Bronchiectasis Drug: Symbicort Drug: Spiriva Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ICS/LABA Group
Symbicort,Inhalation,Individualized medication,12 months.
Drug: Symbicort
drug are used for 12 months
Other Name: Budesonide/Formoterol

Active Comparator: LAMA Group
Tiotropium Bromide,Inhalation,Individualized medication,12 months.
Drug: Spiriva
drug are used for 12 months
Other Name: Tiotropium Bromide

Active Comparator: LAMA+LABA Group
Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months.
Drug: Symbicort
drug are used for 12 months
Other Name: Budesonide/Formoterol

Drug: Spiriva
drug are used for 12 months
Other Name: Tiotropium Bromide




Primary Outcome Measures :
  1. Acute exacerbation [ Time Frame: 12 months ]
    The times of acute exacerbation during the trial.


Secondary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: 12 months ]
    All of the adverse events occurred in the processing of the trial,especially the prevalence of pneumonia.

  2. FEV1 [ Time Frame: 12 months ]
    Forced Expiratory Volume in one second

  3. FVC [ Time Frame: 12 months ]
    Forced Vital Capacity

  4. FEV1/FVC [ Time Frame: 12 months ]
    Pulmonary function test

  5. SGRQ [ Time Frame: 12 months ]
    St. George's Respiratory Questionnaire

  6. LCQ [ Time Frame: 12 months ]
    The Leicester Cough Questionnaire

  7. CAT [ Time Frame: 12 months ]
    COPD Assessment Test

  8. mMRC [ Time Frame: 12 months ]
    Modified Medical Research Council Dyspnea Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546297


Locations
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China, Shanghai
Shanghai Pulmonary Hospital
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
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Principal Investigator: Jin-Fu Xu Shanghai Pulmonary Hospital , Tongji University

Publications of Results:
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Responsible Party: Jin-Fu Xu, Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT02546297    
Other Study ID Numbers: 20150717
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China:
LAMA,ICS+LABA,LAMA+LABA
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Bromides
Tiotropium Bromide
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants