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

Asthma-COPD Overlap Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03504527
• Other study ID #: KY2017-008
• Status: Not yet recruiting
• Phase: N/A
• First received: September 28, 2017
• Last updated: April 12, 2018
• Start date: May 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: April 2018
• Source: Huashan Hospital
• Contact: Li Shengqing, PhD
• Phone: +86-02150887072
• Email: shengqingli[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Half of participants will receive budesonide,formoterol and tiotropium in combination, while the other half will receive budesonide and formoterol only.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 1, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma-COPD Overlap

Intervention

Drug:
• triple combinations
inhaled budesonide(160ug,bid),formotero(4.5ug,bid) and tiotropium bromide(18µg,qd)
• double combinations
inhaled formotero(4.5ug,bid) and tiotropium bromide(18µg,qd)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the frequency of ACO exacerbation	the frequency of ACO exacerbation	12 months
Secondary	postbronchodilator FEV1	a post-bronchodilator forced expiratory volume in one second	12 months
Secondary	times of hospital readmission caused by exacerbation	times of hospital readmission caused by exacerbation	12 months
Secondary	other lung function parameters	other lung function parameters(%FEV1, FEV1/FVC)	12 months
Secondary	CCQ score	Clinical COPD Questionnaire score	12 months
Secondary	mMRC score	modified Medical Research Council score	12 months
Secondary	CAT score	COPD Assessment Test score	12 months
Secondary	ACT score	Asthma Control Test score	12 months