Introduction: There is currently no strategy for identifying chronic obstructive pulmonary disease (COPD) patients whose pulmonary function could benefit from inhaled corticosteroids. We investigated whether a 28-day regime of inhaled corticosteroids improved pulmonary function test results among COPD patients with a fractional exhaled nitric oxide concentration > 35 parts per billion.
Methods: This single-centre one-arm pre–post trial included COPD patients with a fractional exhaled nitric oxide concentration > 35 parts per billion treated at our institution from September 2018 to August 2019. Patients were administered budesonide (200 μg, 8 puffs daily) for 28 days. The primary outcome measure was the difference between the forced expiratory volume in 1 s (FEV1) at baseline and after 28 days of inhaled corticosteroid treatment. Secondary outcomes included differences in COPD Assessment Test scores, %FEV1, and that between the percent forced vital capacity (%FVC) at baseline and after 28 days of treatment.
Results: Twenty patients completed the 28-day inhaled corticosteroid regime. The mean difference in FEV1 between day 1 and day 28 was 340 mL (95% confidence interval: −100 to 770 mL; p = 0.122). The mean differences in secondary outcomes were: %FVC, −0.16% (95% confidence interval [CI]: −2.84 to 2.53%; p = 0.905); %FEV1, 1.63% (95%CI: −4.56 to 7.81%; p = 0.589); COPD Assessment Test score, −2.50 (95%CI: −5.72 to 0.72; p = 0.121).
Conclusion: The 28-day course of inhaled corticosteroids yielded no significant difference in FEV1 for COPD patients with a fractional exhaled nitric oxide concentration > 35 parts per billion.
Trial registration: University Hospital Medical Information Network Center, UMIN000034005. Registered 3 September 2018.
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000038557
Luisetto M, Mashori GR, Cabianca L and Latyshev OYU
Published on: 11th October, 2024
The aim of this work is to verify the pharmaceutical form in the galenic field of oral Budesonide compounded used in Crohn’s disease: capsules delay release or oral suspension. In particular ways the kinds of excipients or bases-vehicle used in the galenic pharmacy practice. The therapeutic need for Crohn’s disease requires a release of the API in delayed-release DR. The Budesonide molecule shows low systemic impacts due to its hepatic metabolism vs. a topical effect useful in this pathology. In this work, the oral pharmaceutical forms are analyzed: modified-release capsules and oral suspension with specific advantages for each one. Some formulations provided by various pharmacies are reported in this work as well as new technology like the 3D-PRINTING systems for colonic targeting tablets.
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