P86 In vitro and clinical characterisation of the antistatic valved holding chamber aerochamber plus® flow-vu® for administrating tiotropium respimat® in 1–5-year-old children with persistent asthmatic symptoms
Bibliographic record
Abstract
Introduction Characterisation of any inhalation product requires a comprehensive assessment including in vitro, pharmacokinetic (PK), and clinical Results We assessed tiotropium Respimat® administered with the AeroChamber Plus® Flow-Vu® antistatic valved holding chamber (test VHC) using in vitro, PK and clinical data in 1–5 year-olds with persistent asthmatic symptoms. Methods We evaluated tiotropium delivered into a cascade impactor under fixed paediatric flow rates with and without holding times in the test VHC. Tidal breathing simulations and an anatomically correct ADAM-III Child Model were employed to assess the tiotropium mass likely to reach the lungs of preschool children when Respimat® was administered with the test VHC. Clinical characterisation was based on a 12 week, randomised trial of once-daily tiotropium Respimat® or placebo as add-on to background therapy in 1–5 year-olds with persistent asthmatic symptoms (NCT01634113). PK data on systemic exposure to tiotropium Respimat® administered with test VHC in preschool children were compared with pooled data from older patients with symptomatic persistent asthma not using VHCs (NCT01383499/NCT01122680/NCT01233284/NCT01152450/NCT01696071/NCT00772538/NCT00776984/NCT01172808/NCT01172821). Results In vitro emitted mass decreased with lower flow conditions, indicating age-dependent dose reduction. In terms of dose per kg/body weight, delivered dosing at flow rates corresponding to preschool children was comparable to that at flow rates corresponding to older children (Table). Transmission and holding properties of tiotropium Respimat® administered by test VHC were fully sufficient for aerosol delivery of patients. Standardised tidal inhalation resulted in emitted mass from the test VHC of approximately one-third of labelled dose, independent of coordination and face mask use, indicating predictable tiotropium administration by Respimat® when used with test VHC. ADAM-III model data correlated well with standardised tidal breathing Results in terms of total mass delivered and mass delivered to filter (available to lungs). In separate clinical trials, tiotropium exposure in 1–5 year-old patients using the test VHC, adjusted by height or body surface, was comparable with that observed in older patients not using VHCs, with no overexposure. Safety of tiotropium Respimat® in 1–5 year-olds was comparable to placebo. Conclusion This study supports administration of tiotropium Respimat® with the AeroChamber Plus® Flow-Vu® VHC in 1–5 year-old children with persistent asthmatic symptoms.
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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".