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

Fudan University

Status: Unknown

Conditions: Asthma-COPD Overlap

Treatments: Drug: double combinations; Drug: triple combinations

Study type: Interventional

Funder types: Other

Identifiers

NCT03504527

KY2017-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

triple combinations

Experimental group

Description:

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

Treatment:

Drug: triple combinations

double combinations

Active Comparator group

Description:

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

Treatment:

Drug: double combinations