The Vietnam COPD Asthma and Prevention of Smoking (VCAPS) 4 Trial

Phase 4

Completed

• Conditions: Respiratory - Chronic obstructive pulmonary disease; COPD; Smoking; Asthma; Respiratory - Asthma; Public Health - Health service research

• Registration Number: ACTRN12620000649910
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-04
• Study Completion: 2023-02-03
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3095

Inclusion Criteria

Inclusion criteria for the chronic respiratory disease (CRD) component:
(a) Patients 12 years old and over, presenting to district health facilities; AND:
(b) Presents with at least one of cough, dyspnoea, wheeze or chest tightness, AND
(c) A history of at least one prior episode of respiratory symptoms requiring assessment by a health care facility (clinic, private doctor, pharmacy or hospital) in the past 24 months; AND
(d) Intends to be resident in the Province for the next 12 months
(e) Patients have a method of being contacted during follow-up (e.g. a personal telephone, or telephone of a relative) and
(f) Meets the definition for asthma or COPD, as defined by:
(i) Probable asthma: Score of three or more YES” responses (out of a total of 9) on the Asthma questionnaire) , OR
(ii) Airflow limitation: either pre-bronchodilator FEV1/FVC ratio < 70% OR (contraindicated or cannot be performed) Peak Expiratory Flow (PEF) <80% predicted at time of presentation;

Inclusion criteria for the smoking cessation (SC) component:
(a) Patients attending the selected health facility AND
(b) Aged 12 years and over; AND
(c) A current smoker (either occasional or daily); AND
(d) Intends to be resident in the Province for the next 12 months; AND
(e) Patients have a method of being contacted during follow-up (e.g. a personal telephone, or telephone of a relative)

Exclusion Criteria

Exclusion criteria for screening:
(a)Patient cannot provide consent (e.g. due to confusion or dementia)
(b)The patient has respiratory failure (e.g. hypoxaemia requiring supplemental oxygen)
(c)The patient is haemodynamically unstable
(d)Patient currently has active tuberculosis
(e)The patient has a history of bronchiectasis, defined as daily cough and production of purulent sputum for at least 6 months.
(f)Patient has one of the following serious health conditions: aortic aneurysm, current cancer, an illness with a prognosis of <1 year
(g)Allergic to budesonide or formoterol
(h)Patient is currently pregnant
(i) Patients will not be enrolled if a probable alternative diagnosis explains the respiratory symptoms.

Exclusion criteria for the SC component:
(a) Unable to give informed consent, with difficulty with communication or severe mental illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(Chronic respiratory disease management component): The proportion of individuals with CRD reporting one or more acute exacerbations over the 12 months after enrolment. [ Within 12 months of enrolment];(Smoking cessation component): The proportion of enrolled smokers who have sustained self-reported and validated smoking cessation twelve months after enrolment.[ Within 12 months of enrolment.]