Retrospective Review on Patients With Recurrent Asthmatic Attacks Requiring Hospitalizations

July 16, 2020 updated by: Ka Pang Chan, Chinese University of Hong Kong
Asthma is a common respiratory disease. around the world. Asthma exacerbation is one of the major sequelae and associated with various morbidity and mortality. A satisfactory asthma control can help to bring down the risk of exacerbation and hence hospitalization. However, the real-world evidence on the clinical factors that leads to multiple admissions, when compared with single admission, due to asthma exacerbation is scarce. This study aimed at evaluating the clinical characteristics of patients who had single and multiple hospitalizations for asthma exacerbations, and exploring the risk factors that predict multiple hospitalizations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Asthma is a common respiratory disease worldwide and in Hong Kong. According to the estimation by the Center for Disease Control and Prevention in 2015, 7.6% adults in the United States have asthma. In Hong Kong, the prevalence of asthma was estimated to be 10.1% among 13 to 14 years old children and 5.8% in randomly selected Chinese elderly aged more than 70. The clinical characteristics varies in different age groups, with elderly asthmatics have higher rates of bronchial hyper-reactivity and more severe phenotypes, when comparing with younger patients. This is more important in an ageing population.

Asthmatic exacerbation is not an uncommon complication and can be fatal. For those patients with near-fatal asthma exacerbation, ICU admission and mechanical ventilation may be necessary to prevent mortality. This is more common among poor controllers and adults. Asthma-related deaths may be reduced if risk factors are recognized and addressed early.

Many predictors for exacerbation had been identified, both endogenous and exogenous, including high eosinophil count, upper airway diseases, gastroesophageal reflux, poor inhaler technique, medication non-compliance, guideline non-compliance. One of the most powerful predictors for future exacerbation in patients with severe or difficult-to-treat asthma is a recent severe asthma exacerbation. In addition, hospitalization for exacerbations requiring ICU care and mechanical ventilation are both predictors for near-fatal asthma. After the acute attack, its unfavourable impact continues and can lead to multiple sequelae. Exacerbation of asthma is associated with a more rapid decline in the post-bronchodilator forced expiratory volume in 1 second and worse quality of life. In addition, individuals with uncontrolled asthma had higher medical expenditures and decreased productivity, contributing to a greater economic burden when compared with individuals without asthma. In contrary, patients with controlled asthma had lower hospitalization rate, mortality rate and less decline in lung function.

Many of these factors are potentially reversible. But, there is still a significant proportion of asthma patients experiencing recurrent exacerbation despite optimization of pharmacological treatment. A model of better asthma care may be established by improving the understanding on these risk factors, leading to less exacerbation events.

Study Type

Observational

Enrollment (Actual)

2280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

By using the International Classification of Diseases, Ninth Revision, Clinical Modification code 493.xx, each participating hospital identified all primary hospital discharge diagnosis of asthma (exacerbation) during a 12-month period, between 1st January 2016 to 31st December 2016

Description

Inclusion Criteria:

  • All patients with hospitalization for asthmatic exacerbation according to physician's clinical judgement
  • Age greater than 18 years old

Exclusion Criteria:

- Inappropriate diagnosis of asthma exacerbation after evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asthma group
Patients with asthma
Other: Asthma exacerbation related hospitalization
Evaluate the difference between patients with single and multiple hospitalizations for asthma exacerbation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who had hospitalization for asthma attack
Time Frame: 1 year
Number of patients who had hospitalization for asthma attack
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burden of comorbidity among subjects with recurrent hospital admission for asthma attack
Time Frame: 1 year
Burden of comorbidity among subjects with recurrent hospital admission for asthma attack
1 year
Spirometric parameters (FEV1, FVC) among subjects with recurrent hospital admission for asthma attack
Time Frame: 1 year
Spirometric parameters (FEV1, FVC) among subjects with recurrent hospital admission for asthma attack
1 year
Baseline blood eosinophil among subjects with recurrent hospital admission for asthma attack
Time Frame: 1 year
Baseline blood eosinophil among subjects with recurrent hospital admission for asthma attack
1 year
Prevalence of asthma patients who had received phenotypic workup
Time Frame: 1 year
Prevalence of asthma patients who had received phenotypic workup
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Queen Elizabeth Hospital, Hong Kong
Queen Mary Hospital, Hong Kong
Kwong Wah Hospital
Pamela Youde Nethersole Eastern Hospital
Princess Margaret Hospital, Hong Kong
United Christian Hospital
Caritas Medical Centre, Hong Kong
North District Hospital, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tseung Kwan O Hospital, Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

June 28, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 16, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC 2017.503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

upon individual approach for metaanalysis or related study

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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