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Budesonide/Formoterol Inhalation Powder in Adults With Asthma

NCT07790159 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2026-08-27

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether budesonide/formoterol powder for inhalation (II) manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd. is non-inferior to the active comparator, Symbicort® Turbuhaler® (AstraZeneca), in the treatment of adult bronchial asthma, and to assess its safety profile in this population.

The main questions it aims to answer are:

Does the test product (budesonide/formoterol 160 μg/4.5 μg) show non-inferior efficacy compared to the reference product (Symbicort® Turbuhaler® 160 μg/4.5 μg) in improving lung function, as measured by the change from baseline in trough FEV1 after 42 days of treatment?

What is the safety profile of the test product in adult patients with asthma?

Researchers will compare participants receiving the test product plus placebo of the comparator to those receiving the active comparator plus placebo of the test product, to see if the test product is non-inferior to the reference product in terms of efficacy, with comparable safety.

Participants will:

Be randomized to receive either the test product (budesonide/formoterol 160 μg/4.5 μg, 2 inhalations twice daily) plus placebo of the comparator, or the active comparator (Symbicort® Turbuhaler® 160 μg/4.5 μg, 2 inhalations twice daily) plus placebo of the test product, for 6 weeks of treatment

Perform daily morning and evening PEF measurements and record them, along with rescue medication use and any adverse events, in a diary card

Attend regular clinic visits for pulmonary function tests, ACQ-5 and AQLQ questionnaires, safety assessments (vital signs, physical and oropharyngeal examinations, laboratory tests, and 12-lead ECG), and drug accountability

Conditions

Interventions

DRUG

Budesonide and Formoterol Fumarate

Budesonide/formoterol 160 μg/4.5 μg per inhalation, administered as 2 inhalations twice daily via the Pingchuan® dry powder inhaler.

DRUG

Placebo of Budesonide and Formoterol Fumarate

Placebo matching the test product, containing inactive excipients only, administered as 2 inhalations twice daily via the Pingchuan® dry powder inhaler.

DRUG

Budesonide and Formoterol Fumarate

Active comparator: Symbicort® Turbuhaler® (budesonide/formoterol 160 μg/4.5 μg per inhalation), administered as 2 inhalations twice daily via the Turbuhaler® dry powder inhaler. Manufactured by AstraZeneca.

DRUG

Placebo of Budesonide and Formoterol Fumarate

Placebo matching the active comparator (Symbicort® Turbuhaler®), containing inactive excipients only, administered as 2 inhalations twice daily via the Turbuhaler® dry powder inhaler.

Sponsors & Collaborators

  • Shanghai Xin Huanghe Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-21
Primary Completion
2024-09-27
Completion
2024-11-07

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07790159 on ClinicalTrials.gov