Stepped treatment algorithm using budesonide-formoterol for chronic respiratory diseases: A single arm interventional study

PLoS One. 2022 Jul 11;17(7):e0271178. doi: 10.1371/journal.pone.0271178. eCollection 2022.

Abstract

Background: While the safety and efficacy of inhaled budesonide-formoterol, used as-needed for symptoms, has been established for patients with asthma, it has not been trialed in undifferentiated patients with chronic respiratory diseases. We aimed to assess the feasibility of a pragmatic intervention that entails a stepped algorithm using inhaled budesonide-formoterol (dry powder inhaler, 160μg/4.5μg per dose) for patients presenting with chronic respiratory diseases to three rural district hospitals in Hanoi, Vietnam.

Methods: We recruited patients with evidence of airflow obstruction on spirometry and/or symptoms consistent with asthma. The algorithm consisted of three steps: 1. as-needed inhaled budesonide-formoterol for symptoms, 2. maintenance plus as-needed inhaled budesonide-formoterol, and 3. referral to a higher-level healthcare facility. All participants started at step 1, with escalation to the next step at review visits if there had been exacerbation(s) or inadequate symptom control. Patients were followed for 12 months.

Results: Among 313 participants who started the treatment algorithm, 47.2% had ≥ 1 episode of acute respiratory symptoms requiring a visit to hospital or clinic and 35.4% were diagnosed with an exacerbation. Twelve months after enrolment, 50.7% still adhered to inhaled budesonide-formoterol at the recommended treatment step. The mean and median number of doses per day was 1.5 (standard deviation 1.2) doses and 1.3 (interquartile range 0.7-2.3) doses, respectively. The proportion of patients taking more than 800μg budesonide per day was 3.8%.

Conclusion: This novel therapeutic algorithm is feasible for patients with chronic respiratory diseases in a rural setting in Vietnam. Further studies are required to establish the effectiveness, safety and cost-effectiveness of similar approaches in different settings.

Trial registration: ACTRN12619000554167.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Algorithms
  • Anti-Asthmatic Agents* / therapeutic use
  • Asthma* / chemically induced
  • Asthma* / drug therapy
  • Bronchodilator Agents
  • Budesonide
  • Drug Combinations
  • Ethanolamines / therapeutic use
  • Formoterol Fumarate / therapeutic use
  • Humans
  • Respiration Disorders* / drug therapy
  • Treatment Outcome

Substances

  • Anti-Asthmatic Agents
  • Bronchodilator Agents
  • Drug Combinations
  • Ethanolamines
  • Budesonide
  • Formoterol Fumarate

Associated data

  • ANZCTR/ACTRN12619000554167

Grants and funding

This work was supported by a project grant funded through the Australian National Health and Medical Research Council (https://www.nhmrc.gov.au/; NHMRC APP1116020), in collaboration with the Global Alliance for Chronic Disease. WCH was supported by the University International Postgraduate Award funded by the University of New South Wales. GJF was supported by a Australian National Health and Medical Research Council Career Development Fellowship (APP1148372). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.