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Bolieva L.Z.

North Ossetian State Medical Academy

Manko K.S.

Akrikhin JSC

Kryzhanovskiy S.M.

OOO «Ligand Research»

Results of an open-label, randomized, multicenter, comparative study of clinical efficacy and safety of Pulmibud drug and Pulmicort drug in patients with partially controlled and uncontrolled persistent bronchial asthma

Authors:

Bolieva L.Z., Manko K.S., Kryzhanovskiy S.M.

More about the authors

Journal: Journal of Respiratory Medicine. 2025;1(3): 33‑38

DOI: 10.17116/respmed2025103133

Read: 231 times

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RESULTS OF AN OPEN-LABEL, RANDOMIZED, MULTICENTER, COMPARATIVE STUDY OF CLINICAL EFFICACY AND SAFETY OF PULMIBUD DRUG AND PULMICORT DRUG IN PATIENTS WITH PARTIALLY CONTROLLED AND UNCONTROLLED PERSISTENT BRONCHIAL ASTHMA
RESULTS OF AN OPEN-LABEL, RANDOMIZED, MULTICENTER, COMPARATIVE STUDY OF CLINICAL EFFICACY AND SAFETY OF PULMIBUD DRUG AND PULMICORT DRUG IN PATIENTS WITH PARTIALLY CONTROLLED AND UNCONTROLLED PERSISTENT BRONCHIAL ASTHMA

To cite this article:

Bolieva LZ, Manko KS, Kryzhanovskiy SM. Results of an open-label, randomized, multicenter, comparative study of clinical efficacy and safety of Pulmibud drug and Pulmicort drug in patients with partially controlled and uncontrolled persistent bronchial asthma. Journal of Respiratory Medicine. 2025;1(3):33‑38. (In Russ.)
https://doi.org/10.17116/respmed2025103133

Подписка 2026 Респираторная медицина (Journal of Respiratory Medicine)
 
МСФ на ЯМ
Использование инфографики авторами научных работ
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Abstract:

A prospective, open-label, randomized, multicenter, comparative, phase III study was performed for the purpose of evaluating non-inferiority and safety of «Pulmibud» budesonide inhalation suspension (AO «AKRIKHIN», Russia) in comparison with Pulmicort reference product (AstraZeneka) in patients with partially controlled and uncontrolled persistent bronchial asthma.

MATERIALS AND METHODS

The study included 160 patients randomized into two equal groups (n=80): «Pulmibud» group and Pulmicort group. The primary efficacy endpoint was the dynamics of the mean incremental FEV1 on the 84th day of therapy compared to the baseline. The margin of non-inferiority amounted to 200 ml, which corresponds to the upper range of clinically significant difference for adult patients with asthma.

RESULTS

Similar changes in the primary and secondary endpoints have been achieved in all groups: mean increase of FEV1 was 111.4±376.1 ml in the «Pulmibud» group and 122.1±372.4 ml in the Pulmicort group (difference —10.7±109.6 ml; p=0.9315), which confirmed the non-inferiority hypothesis. The safety profile was also comparable: 50 adverse events (31.25% of patients) in the «Pulmibud» group and 52 (30.00%) in the Pulmicort group.

CONCLUSION

The study results demonstrate the therapeutic equivalence of «Pulmibud» generic drug and original Pulmicort in adult patients with persistent bronchial asthma.

Keywords:

bronchial asthma
budesonide
inhalation suspension
non-inferiority
safety
randomized study

Authors:

Bolieva L.Z.

North Ossetian State Medical Academy

Manko K.S.

Akrikhin JSC

Kryzhanovskiy S.M.

OOO «Ligand Research»

Received:

20.08.2025

Accepted:

30.09.2025

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References:

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  9. U.S. FDA. Product-Specific Guidance: Budesonide; Formoterol Fumarate; Glycopyrrolate Inhalation Metered Aerosol (PSG_212122). Recommended Feb 2024. Accessed September 26, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212122.pdf
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