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Efficiency of Budesonide Combined With Formoterol and Tiotropium in the Treatment of Acute Exacerbation of ACO

Primary Purpose

Asthma-COPD Overlap

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
triple combinations
double combinations
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma-COPD Overlap focused on measuring ICS, LABA, LAMA, therapy, asthma, COPD, ACO

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • subject has ACO

Exclusion Criteria:

  • acute exacerbation of ACO;
  • acute infection;
  • postbrochodilator FEV1/FVC> 0.7;
  • pulmonary complications: bronchiectasis, active tuberculosis, pulmonary fungal disease or lung cancer
  • history of other malignant tumor
  • with rheumatic diseases;
  • with some serious heart, cerebrovascular, liver, kidney or hematopoietic system diseases
  • with tachyarrhythmias；
  • mental patients;
  • with moderate to severe renal insufficiency (creatinine clearance ≤ 50ml / h)
  • allergic to the budesonide, formoterol or tiotropium bromide;
  • history of acute gastrointestinal bleeding within 3 months;
  • with severe angle closure glaucoma patients;
  • pregnancy,lactation;
  • have participated in other clinical trials in 3 months；
  • hospital staff and their relatives

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    triple combinations

    double combinations

    Arm Description

    Budesonide/Fermotil inhalant 160ug/4.5ug bid; Tiotropium bromide inhalants 18ug qd

    Fermotil inhalants 4.5ug bid; Tiotropium bromide inhalants 18ug qd

    Outcomes

    Primary Outcome Measures

    the frequency of ACO exacerbation
    the frequency of ACO exacerbation

    Secondary Outcome Measures

    postbronchodilator FEV1
    a post-bronchodilator forced expiratory volume in one second
    times of hospital readmission caused by exacerbation
    times of hospital readmission caused by exacerbation
    other lung function parameters
    other lung function parameters(%FEV1, FEV1/FVC)
    CCQ score
    Clinical COPD Questionnaire score
    mMRC score
    modified Medical Research Council score
    CAT score
    COPD Assessment Test score
    ACT score
    Asthma Control Test score

    Full Information

    First Posted
    September 28, 2017
    Last Updated
    April 12, 2018
    Sponsor
    Huashan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03504527
    Brief Title
    Efficiency of Budesonide Combined With Formoterol and Tiotropium in the Treatment of Acute Exacerbation of ACO
    Official Title
    Effeciency of Budesonide Combined With Formoterol and Tiotropium in the Treatment of Acute Exacerbation of Asthma-chronic Obstructive Pulmonary Overlap: A Randomized Controlled Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2018 (Anticipated)
    Primary Completion Date
    November 1, 2018 (Anticipated)
    Study Completion Date
    May 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Huashan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluates the efficiency of ICS(budesonide) combined with LABA (formoterol) and LAMA(tiotropium) in the treatment of acute exacerbation of asthma-chronic obstructive pulmonary overlap. Half of participants will receive budesonide,formoterol and tiotropium in combination, while the other half will receive budesonide and formoterol only.
    Detailed Description
    ACO(asthma-chronic obstructive pulmonary overlap) is a relatively new proposed clinical form of chronic airway disease. Guideline or preferring therapy for ACO is still evolving. Current clinical solution is when ACO presents like asthma, initial treatment will accord to the guideline for asthma , while it presents like COPD, COPD recommendation treatment (not alone ICS,but ICS in addition of LABA with or without LAMA) will be chosen, which are subjective. Although present guidelines has recommended that ACO should be treated with at last two inhalant, but limited date have proven it. A random controlled trial will be conducted to evaluate the efficiency of ICS(budesonide) combined with LABA (formoterol) and LAMA(tiotropium bromide) in the treatment of acute exacerbation of ACO,compared with the control group receiving tiotropium bromide with formoterol only.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma-COPD Overlap
    Keywords
    ICS, LABA, LAMA, therapy, asthma, COPD, ACO

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    triple combinations
    Arm Type
    Experimental
    Arm Description
    Budesonide/Fermotil inhalant 160ug/4.5ug bid; Tiotropium bromide inhalants 18ug qd
    Arm Title
    double combinations
    Arm Type
    Active Comparator
    Arm Description
    Fermotil inhalants 4.5ug bid; Tiotropium bromide inhalants 18ug qd
    Intervention Type
    Drug
    Intervention Name(s)
    triple combinations
    Other Intervention Name(s)
    budesonide/formotero/tiotropium bromide triple combinations
    Intervention Description
    inhaled budesonide(160ug,bid),formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)
    Intervention Type
    Drug
    Intervention Name(s)
    double combinations
    Other Intervention Name(s)
    formotero/tiotropium bromide double combinations
    Intervention Description
    inhaled formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)
    Primary Outcome Measure Information:
    Title
    the frequency of ACO exacerbation
    Description
    the frequency of ACO exacerbation
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    postbronchodilator FEV1
    Description
    a post-bronchodilator forced expiratory volume in one second
    Time Frame
    12 months
    Title
    times of hospital readmission caused by exacerbation
    Description
    times of hospital readmission caused by exacerbation
    Time Frame
    12 months
    Title
    other lung function parameters
    Description
    other lung function parameters(%FEV1, FEV1/FVC)
    Time Frame
    12 months
    Title
    CCQ score
    Description
    Clinical COPD Questionnaire score
    Time Frame
    12 months
    Title
    mMRC score
    Description
    modified Medical Research Council score
    Time Frame
    12 months
    Title
    CAT score
    Description
    COPD Assessment Test score
    Time Frame
    12 months
    Title
    ACT score
    Description
    Asthma Control Test score
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: subject has ACO Exclusion Criteria: acute exacerbation of ACO; acute infection; postbrochodilator FEV1/FVC> 0.7; pulmonary complications: bronchiectasis, active tuberculosis, pulmonary fungal disease or lung cancer history of other malignant tumor with rheumatic diseases; with some serious heart, cerebrovascular, liver, kidney or hematopoietic system diseases with tachyarrhythmias； mental patients; with moderate to severe renal insufficiency (creatinine clearance ≤ 50ml / h) allergic to the budesonide, formoterol or tiotropium bromide; history of acute gastrointestinal bleeding within 3 months; with severe angle closure glaucoma patients; pregnancy,lactation; have participated in other clinical trials in 3 months； hospital staff and their relatives
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Li Shengqing, PhD
    Phone
    +86-02150887072
    Email
    shengqingli@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhang Xia, PhD
    Phone
    +86-02150887073
    Email
    xiangruye@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Li Shengqing, PhD
    Organizational Affiliation
    Huashan Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Efficiency of Budesonide Combined With Formoterol and Tiotropium in the Treatment of Acute Exacerbation of ACO

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