NCT02546297

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.

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
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_4

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

July 22, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
2 years until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

3 years

First QC Date

July 22, 2015

Last Update Submit

July 29, 2019

Conditions

COPDBronchiectasis

Keywords

LAMA,ICS+LABA,LAMA+LABA

Outcome Measures

Primary Outcomes (1)

  • Acute exacerbation

    The times of acute exacerbation during the trial.

    12 months

Secondary Outcomes (8)

  • Number of patients with adverse events

    12 months

  • FEV1

    12 months

  • FVC

    12 months

  • FEV1/FVC

    12 months

  • SGRQ

    12 months

  • +3 more secondary outcomes

Study Arms (3)

ICS/LABA Group

ACTIVE COMPARATOR

Symbicort，Inhalation，Individualized medication，12 months.

Drug: Symbicort

LAMA Group

ACTIVE COMPARATOR

Tiotropium Bromide，Inhalation,Individualized medication，12 months.

Drug: Spiriva

LAMA+LABA Group

ACTIVE COMPARATOR

Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months.

Drug: SymbicortDrug: Spiriva

Interventions

SymbicortDRUG

drug are used for 12 months

Also known as: Budesonide/Formoterol
ICS/LABA GroupLAMA+LABA Group
SpirivaDRUG

drug are used for 12 months

Also known as: Tiotropium Bromide
LAMA GroupLAMA+LABA Group

Eligibility Criteria

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (3)

  • 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. eCollection 2014.

    PMID: 24872685RESULT

  • 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;2014(3):CD010844. doi: 10.1002/14651858.CD010844.pub2.

    PMID: 24671923RESULT

  • 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 2014 Jun 22.

    PMID: 24952426RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchiectasis

Interventions

Budesonide, Formoterol Fumarate Drug CombinationTiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Formoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBudesonidePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Jin-Fu Xu

    Shanghai Pulmonary Hospital , Tongji University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Respiratory Medicine

Study Record Dates

First Submitted

July 22, 2015

First Posted

September 10, 2015

Study Start

September 15, 2017

Primary Completion

September 15, 2020

Study Completion

March 1, 2021

Last Updated

August 1, 2019

Record last verified: 2019-07

Locations

CN(1)