A Randomized, Double-Blind, Double-Dummy, Safety Crossover Trial Comparing Cumulative Doses up to 96 μg of Formoterol Delivered via an HFA-134a-Propelled pMDI vs. Same Cumulative Doses of Formoterol DPI and Placebo in Asthmatic Patients
Bibliographic record
Abstract
BACKGROUND: Formoterol's effects on the cardiovascular system are well known, but whether these effects are altered by the reformulation of inhalers to replace CFC propellants with HFA propellants is not. OBJECTIVES: To evaluate the effect of cumulative doses up to 96 microg of formoterol delivered via an HFA-134a-propelled pMDI, on cardiac safety and the QTc interval, compared the same cumulative doses delivered via a DPI, in adult patients with moderate-to-severe asthma. METHODS: This study was a multicenter, double-blind, double-dummy, placebo-controlled, three-period, crossover trial in which 22 patients with moderate-to-severe asthma received cumulative doses up to 96 microg of formoterol (12 + 12 + 24 + 48 microg) delivered via a pMDI or a dry power inhaler (DPI). Vital signs and fourteen 12-lead ECG measurements were taken at each clinic visit and at 5-10 days after the final drug administration. RESULTS: An increase from baseline in QTc interval was observed with all formoterol treatment arms in a dose-dependent manner. The maximum increases were 56.3, 62.6 and 25.0 ms for the formoterol pMDI, formoterol DPI and placebo treatments, respectively. Heart rate was increased by 10.7, 14.9 and 6.5 bpm in the pMDI, DPI and placebo groups, respectively. Both formoterol treatments were also associated with a decrease in diastolic blood pressure compared with placebo. CONCLUSIONS: With respect to cardiovascular safety parameters, the administration of formoterol via a pMDI device is comparable to its delivery via a DPI.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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".