Clinical Impact of a Digital Dose Counter Pressurized Metered-Dose Inhaler on Uncontrolled Asthma: Cross-Sectional, Observational, Surveillance Study
Bibliographic record
Abstract
BACKGROUND: In India, control of asthma with persistent symptoms remains a clinical enigma with likely incriminating factors including non- and pseudoadherence to the inhaled corticosteroids and long-acting beta2-agonists. The United States Food and Drug Administration guidance recommends the use of dose counter pressurized metered-dose inhalers (pMDIs) with further mechanisms to track adherence and pseudoadherence in real-world settings. OBJECTIVE: Digital dose counter pMDIs (dpMDIs) offer simplified, reliable tracking of individual "actuated" dosages with "END" display at completion of the labelled therapeutic aerosol spray. The translational impact on symptom persistence with likely unwarranted exposure to the "Step up" strategy is often prevented if not treated, as in the cases of "pseudo" severe asthma. To further assess the real-world acceptance and clinical impact of dpMDIs in bronchial asthma including poorly controlled or uncontrolled bronchial asthma cases, a noninterventional observational study was performed. METHODS: This cross-sectional, retrospective, case cohort, observational study-the Drug Utilization Surveillance-of dpMDIs in bronchial asthma was conducted in September 2016 in an outpatient setting in India. The retrospective analysis was initiated and conducted as per the International Conference on Harmonization Good Clinical Practice principles and Declaration of Helsinki, following approval from the local ethics committee and registration in the Clinical Trial Registry of India. RESULTS: Consecutive cases of moderate-to-severe asthma with poor control (n=4575), diagnosed as per the Global Initiative for Asthma symptom scale at baseline and follow-up, were included. Patients under treatment using dpMDIs were enrolled from 500 centers across India and assessed by respiratory care specialists. Baseline asthma control was assessed as partly controlled (n=4575) or poorly controlled (n=2942). Per protocol analyses showed that asthma was well controlled with dpMDIs at 8 weeks in 92.7% of the cases (2727/2942, P<.001). Adverse events (n=106, 2%) of mild-to-moderate intensity were reported. Nebulization was required in two patients with episodic breathlessness who were discharged with no consequent sequelae. Post hoc analyses for patients with baseline poorly controlled asthma who "switched" exclusively to dpMDI monotherapy or a combination with xanthines or long-acting beta2-agonists showed a "well controlled" asthma status in 85.9% (500/582, P=.04), 95.4% (395/414, P=.048), and 80.3% (106/132, P=.28) of the cases, respectively. The patient acceptability criteria for an "empty" canister was well correlated with the clinical strategy to identify and avoid pseudoadherence in poorly controlled or difficult-to-treat asthma cases, especially in patients who "switched" exclusively to dpMDIs (n=582) and demonstrated responses of "Use till twenty dose display" (65/156, 41.6%), "Use till END display" (83/156, 53.2%), and "Use till LAST spray" (8/156, 5.1%). CONCLUSIONS: dpMDIs offer simple, accurate, and reliable tracking of non- and pseudoadherence while highlighting incremental asthma-control rates in severe and pseudosevere asthma cases before risk assessment for further "add-on" therapy. TRIAL REGISTRATION: Clinical Trials Registry - India CTRI/2018/06/014595; http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php? trialid=24583.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".