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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-05-01

Brief Summary

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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.

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Detailed Description

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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

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Asthma-COPD Overlap

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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triple combinations

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

Group Type EXPERIMENTAL

triple combinations

Intervention Type DRUG

inhaled budesonide(160ug,bid),formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)

double combinations

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

Group Type ACTIVE_COMPARATOR

double combinations

Intervention Type DRUG

inhaled formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)

Interventions

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triple combinations

inhaled budesonide(160ug,bid),formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)

Intervention Type DRUG

double combinations

inhaled formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)

Intervention Type DRUG

Other Intervention Names

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budesonide/formotero/tiotropium bromide triple combinations formotero/tiotropium bromide double combinations

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No