A Randomized, Double-Blind, Double-Dummy, Single-Dose, Crossover Trial Evaluating the Efficacy and Safety Profiles of Two Dose Levels (12 and 24 μg) of Formoterol-HFA (pMDI) vs. Those of a Dose Level (24 μg) of Formoterol-DPI (Foradil<sup>®</sup>/Aerolizer<sup>™</sup>) and of Placebo (pMDI or Aerolizer) in Moderate to Severe Asthmatic Patients
Bibliographic record
Abstract
BACKGROUND: Chlorofluorocarbons (CFCs) have traditionally been used as propellants in pressurized metered-dose inhalers (pMDIs), which are often used to deliver drugs to the lungs for the treatment of reversible obstructive airways diseases. However, CFCs are harmful to the environment and need to be phased out. In response to that phase-out of environmentally harmful CFCs, the pharmaceutical industry is developing a new generation of pMDI formulations for the inhaled treatment of asthma. These formulations contain hydrofluoroalkanes (HFAs) in redesigned metered-dose inhalers. OBJECTIVES: This study primarily sought to establish clinical equivalence between a new HFA-formulated formoterol pMDI and the conventional formoterol DPI in the treatment of patients with moderate-to-severe asthma. METHODS: We enrolled 51 patients aged 18-70 years old who had stable persistent asthma. All patients were randomized to receive a single dose of each of the following 4 treatments in a double-blind, crossover manner: formoterol HFA pMDI 24 microg, formoterol HFA pMDI 12 microg, formoterol DPI 24 microg or placebo. RESULTS: Of the 51 patients randomised, 46 were evaluable for efficacy. The 12-hour average FEV1 was 2.885, 2.746, 2.916 and 2.353 liters in the HFA 24-microg, HFA 12-microg, DPI 24-microg and placebo groups, respectively. Assessment of 95% CIs revealed that the HFA pMDI 24-microg and DPI formulations were equivalent and that both were significantly superior to placebo (p < 0.001). Improvements in lung function were also significantly superior to placebo in the HFA 12-microg group, but the effect was more moderate than that observed in the higher dose groups. CONCLUSIONS: This study indicates that the formoterol HFA-formulated pMDI provides equivalent bronchodilating effect to the formoterol DPI at the 24-microg dose.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".