JMIR Publications

ABSTRACT

Background:

Asthma control with Persistent symptoms in India remains a clinical enigma with likely incriminating factors including Non- &/or Pseudo-adherence to the ICS/LABA. USFDA guidance recommends the use of dose-counter pMDIs with further mechanisms to track Adherence & Pseudoadherence in real-world settings

Objective:

Digital dose counter pMDIs offers simplified reliable tracking of individual ‘actuated’ dosages with ‘END’ display at the completion of labelled therapeutic aerosol spray. The translational impact on Symptom persistence with likely unwarranted exposure to ‘Step up’ strategy is often prevented if not treated as in these cases of ‘Pseudo’ Severe Asthma .To further assess the real-world acceptance and clinical impact of Digital dose-counter pMDIs, in Bronchial asthma including Poorly or Uncontrolled bronchial asthma cases, an non-interventional, observational study was planned.

Methods:

A national, retrospective, case cohort analyses as Drug Utilization Surveillance study for Digital pMDIs in Br. asthma was conducted in Sept ’16 for outpatient settings of India. The retrospective analyses was initiated and conducted as per ICH GCP principles and Declaration of Helsinki following study documents approval by local Ethics committee approval with Clinical Trial Registry of India registration.

Results:

Consecutive cases of Moderate to Severe asthma with baseline GINA assessed partly- or uncontrolled status (n=4575) on Digital dose-counter pMDIs (dpMDIs) from 500 centers across India were available for this retrospective analyses. Baseline Asthma control was assessed as Partly (4575) and Uncontrolled status (2942) cases respectively. Per protocol analyses for Well controlled Asthma at 8th week with dpMDIs was observed in 92.7 % cases (2727/2942, p<0.0001) for above group. Adverse events (106, 2%) of mild to moderate intensity were reported. Nebulization was required in two cases with episodic breathlessness and discharged with no consequent sequelae. Post hoc analyses for baseline poorly controlled cases who ‘Switched’ exclusively on Digital dose-counter pMDIs monotherapy or combination with Xanthines or LAMAs showed ‘Well control’ asthma status of 85.9% (500/582, p=0.044) , 95.4% (395/414, p=0.048), 80.3% (106/132, p=0.28). The patient acceptability criteria for ‘Empty’ canister well correlated with the clinical strategy to identify and avoid Pseudoadherence in baseline poorly controlled or difficult –to- treat asthma cases especially in the patients who ‘Switched’ exclusively to Digital pMDIs (582) demonstrating responses viz. ‘Use till Twenty dose display’ (65/156, 41.6%), ‘Use till END display (83/156, 53.2%), ‘Use till LAST spray’ (8/156, 5.1%)

Conclusions:

Digital pMDIs offers Simple, accurate & reliable tracking of Non- & Pseudoadherence while highlighting incremental Asthma control rates in Severe or Pseudo-Severe Asthma cases before risk assessment for further ‘add-on’ therapy Clinical Trial: Clinical Trial Registry - India: CTRI/2018/06/014595