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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03504527
Recruitment Status : Unknown
Verified April 2018 by Shengqing Li, Huashan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Shengqing Li, Huashan Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Asthma-COPD Overlap Drug: triple combinations Drug: double combinations Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: triple combinations
Budesonide/Fermotil inhalant 160ug/4.5ug bid; Tiotropium bromide inhalants 18ug qd
 Drug: triple combinations
inhaled budesonide(160ug,bid),formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)
Other Name: budesonide/formotero/tiotropium bromide triple combinations
Active Comparator: double combinations
Fermotil inhalants 4.5ug bid; Tiotropium bromide inhalants 18ug qd
 Drug: double combinations
inhaled formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)
Other Name: formotero/tiotropium bromide double combinations


Outcome Measures
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Primary Outcome Measures :
  1. the frequency of ACO exacerbation [ Time Frame: 12 months ]
    the frequency of ACO exacerbation


Secondary Outcome Measures :
  1. postbronchodilator FEV1 [ Time Frame: 12 months ]
    a post-bronchodilator forced expiratory volume in one second

  2. times of hospital readmission caused by exacerbation [ Time Frame: 12 months ]
    times of hospital readmission caused by exacerbation

  3. other lung function parameters [ Time Frame: 12 months ]
    other lung function parameters(%FEV1, FEV1/FVC)

  4. CCQ score [ Time Frame: 12 months ]
    Clinical COPD Questionnaire score

  5. mMRC score [ Time Frame: 12 months ]
    modified Medical Research Council score

  6. CAT score [ Time Frame: 12 months ]
    COPD Assessment Test score

  7. ACT score [ Time Frame: 12 months ]
    Asthma Control Test score


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504527


Contacts
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Contact: Li Shengqing, PhD +86-02150887072 shengqingli@hotmail.com
Contact: Zhang Xia, PhD +86-02150887073 xiangruye@126.com

Sponsors and Collaborators
Huashan Hospital
Investigators
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Principal Investigator: Li Shengqing, PhD Huashan Hospital
More Information
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Responsible Party: Shengqing Li, Chief physician, professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT03504527    
Other Study ID Numbers: KY2017-008
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shengqing Li, Huashan Hospital:
ICS
LABA
LAMA
therapy
 asthma
COPD
ACO
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Bromides
Tiotropium Bromide
Anti-Inflammatory Agents
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants