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Corticosteroid

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg for Asthma

Phase 3
Waitlist Available
Led By Orlando Rivero, MD
Research Sponsored by Cipla Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time 0 to 12 hours
Awards & highlights

Study Summary

This trial will show if a generic asthma medication is as effective as the brand name medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time 0 to 12 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time 0 to 12 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the serial Force Expiration volume1
Change in FEV1 from baseline
Secondary outcome measures
Assessment of vital signs: Pulse rate
Assessment of vital signs: Systolic and diastolic Blood Pressures
Number and Severity of Adverse Events and Serious Adverse Events
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μgExperimental Treatment1 Intervention
Inhalation Aerosol, 2 actuations orally inhaled twice daily
Group II: Symbicort®Active Control1 Intervention
Inhalation Aerosol, 2 actuations orally inhaled twice daily
Group III: Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μgPlacebo Group1 Intervention
Inhalation Aerosol, 2 actuations orally inhaled twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg
2022
Completed Phase 3
~1490

Find a Location

Who is running the clinical trial?

Cipla Ltd.Lead Sponsor
8 Previous Clinical Trials
27,136 Total Patients Enrolled
3 Trials studying Asthma
1,596 Patients Enrolled for Asthma
Orlando Rivero, MDPrincipal InvestigatorGlobal Research Solution

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient
2022. "BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05322707.
~495 spots leftby Apr 2025
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