Asthma-COPD OverlapNCT03504527
Efficiency of Budesonide Combined With Formoterol and Tiotropium in the Treatment of Acute Exacerbation of ACO
A study testing triple combinations and double combinations in people with Asthma-COPD Overlap, run by Huashan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma-COPD Overlap
- What is being tested?
- triple combinations and double combinations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subject has ACO
Who cannot join
- 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;
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Asthma-COPD Overlap
- Being tested
- triple combinations, double combinations
- Keywords
- ICS, LABA, LAMA, therapy, asthma, COPD, ACO
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triple combinationsDrug
Also called budesonide/formotero/tiotropium bromide triple combinations
inhaled budesonide(160ug,bid),formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)
double combinationsDrug
Also called formotero/tiotropium bromide double combinations
inhaled formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)
| Study group | Role | What they receive |
|---|---|---|
| triple combinations | Experimental | Budesonide/Fermotil inhalant 160ug/4.5ug bid; Tiotropium bromide inhalants 18ug qd Receives: Drug: triple combinations |
| double combinations | Active comparator | Fermotil inhalants 4.5ug bid; Tiotropium bromide inhalants 18ug qd Receives: Drug: double combinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
the frequency of ACO exacerbation
the frequency of ACO exacerbation
Measured: 12 months
Secondary outcomes (7)
postbronchodilator FEV1
a post-bronchodilator forced expiratory volume in one second
Measured: 12 months
times of hospital readmission caused by exacerbation
times of hospital readmission caused by exacerbation
Measured: 12 months
other lung function parameters
other lung function parameters(%FEV1, FEV1/FVC)
Measured: 12 months
CCQ score
Clinical COPD Questionnaire score
Measured: 12 months
mMRC score
modified Medical Research Council score
Measured: 12 months
CAT score
COPD Assessment Test score
Measured: 12 months
ACT score
Asthma Control Test score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma-COPD OverlapStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengqing Li, Huashan Hospital
- Investigators
- Li Shengqing, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504527
- Sponsor's protocol ID
- KY2017-008
- Status last verified
- Apr 2018
- First submitted
- 28 Sep 2017
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03504527
- Acronym / sponsor ID
- KY2017-008
- Conditions
- Asthma-COPD Overlap
- Keywords
- ICS, LABA, LAMA, therapy, asthma, COPD, ACO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triple combinations | Experimental | Drug: triple combinationsBudesonide/Fermotil inhalant 160ug/4.5ug bid; Tiotropium bromide inhalants 18ug qd |
| double combinations | Active comparator | Drug: double combinationsFermotil inhalants 4.5ug bid; Tiotropium bromide inhalants 18ug qd |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subject has ACO
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| triple combinationsAlso: budesonide/formotero/tiotropium bromide triple combinationsinhaled budesonide(160ug,bid),formotero(4.5ug,bid) and tiotropium bromide(18μg,qd) | Drug | triple combinations |
| double combinationsAlso: formotero/tiotropium bromide double combinationsinhaled formotero(4.5ug,bid) and tiotropium bromide(18μg,qd) | Drug | double combinations |
Primary outcome
the frequency of ACO exacerbation
Time frame: 12 months
the frequency of ACO exacerbation
7 secondary outcomes
postbronchodilator FEV1
Time frame: 12 months
times of hospital readmission caused by exacerbation
Time frame: 12 months
other lung function parameters
Time frame: 12 months
CCQ score
Time frame: 12 months
mMRC score
Time frame: 12 months
CAT score
Time frame: 12 months
ACT score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Shengqing, PhD principal investigator
Huashan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing triple combinations and double combinations in people with Asthma-COPD Overlap, run by Huashan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Shengqing, PhD (+86-02150887072, shengqingli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the frequency of ACO exacerbation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.