NCT02866357

Brief Summary

To assess the infective etiologies by quantitative polymerase chain reaction (qPCR) of acute exacerbation of COPD and asthma who required hospitalization. To identify the HRV subtypes that are associated with COPD and asthmaexacerbations. To assess if the infective aetiologies have associations with the clinical outcome of the patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

2.3 years

First QC Date

August 10, 2016

Last Update Submit

January 31, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of different types of viruses

    Prevalence of different types of viruses

    1 month

Secondary Outcomes (1)

  • Clincial outcomes

    60 days

Interventions

Just collection of nasopharyngeal aspirate for assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Asthma and COPD patients

You may qualify if:

  • For COPD patients, patients who are admitted to the Prince of Wales Hospital with AECOPD will be screened for this study. AECOPD is defined when a patient with background COPD (with lung function parameters of FEV1/FVC ratio \<70%)24 presented with at least two of the following major symptoms (increased dyspnoea, increased sputum purulence, increased sputum volume) or one major and one minor symptom (nasal discharge/congestion, wheeze, sore throat, cough) for at least two consecutive days.25,26
  • Patients who has background COPD as mentioned above fulfilling the exacerbation criteria
  • Age ≥40 years
  • For asthma patients, patients who are admitted to the Prince of Wales Hospital with asthma exacerbation will be screened for this study. Acute exacerbation of asthma is defined when an asthma patient presents with increasing dyspnea, wheeze or cough.
  • Patients who has background asthma (defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 400 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable)6 with any of the above exacerbation criteria for at least 2 consecutive days.
  • Age ≥18 years
  • Control asthma and COPD subjects will be recruited from the respiratory clinic of the Prince of Wales Hospital. Subjects will be matched for age, sex and lung function of the COPD and asthma subjects. All recruited COPD subjects should have FEV1/FVC ratio of \<70%. For asthma patients, they should have a clinical diagnosis of asthma (defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 400 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable). These subjects should have no exacerbation of asthma or COPD 6 weeks prior to the assessment.

You may not qualify if:

  • History of lung resection or other significant pulmonary disease like pulmonary fibrosis.
  • Active infection like pulmonary tuberculosis
  • Unable to complete assessment due to physical and/or cognitive impairment
  • Having short life expectancy like subjects with terminal malignancy or intractable heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (1)

  • Ko FW, Chan PK, Chan RWY, Chan KP, Ip A, Kwok A, Ngai JC, Ng SS, On CT, Hui DS. Molecular detection of respiratory pathogens and typing of human rhinovirus of adults hospitalized for exacerbation of asthma and chronic obstructive pulmonary disease. Respir Res. 2019 Sep 13;20(1):210. doi: 10.1186/s12931-019-1181-0.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal aspirate

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David S Hui, MD

    Chinese University of Hong Kong

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Associate Professor

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 15, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 1, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations