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

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
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
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
Learn more about this trial
Efficiency of Budesonide Combined With Formoterol and Tiotropium in the Treatment of Acute Exacerbation of ACO
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