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

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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)

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

Trial contacts and locations

0

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Central trial contact

Li Shengqing, PhD; Zhang Xia, PhD

Data sourced from clinicaltrials.gov

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