AsthmaPhase 3NCT05322707
BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient
A Phase 3 study testing Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg and Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol in people with Asthma, run by Cipla Ltd. at 1 site in United States.
Trial summary
The purpose of the study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in adult patient with Asthma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg and Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,485 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2022to 29 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients who are 18-70 years of age
- Has moderate-to-severe asthma with a pre-bronchodilator FEV1 of ≥45% and <80% of the predicted normal value for the patient after withholding bronchodilators
- Has ≥15% and ≥0.20 L reversibility of FEV1 within 30 minutes following administration of 360 μg of albuterol (pMDI)
- Is stable on current chronic asthma treatment (documented asthma diagnosis and/or prescription for asthma medications) for at least 4 weeks prior to screening visit (Visit 1).
- Has been diagnosed with asthma as defined by the National Asthma Education and Prevention Program (NAEPP 2007) at least 6 months prior to screening
- Adult male or female patients of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control
Who cannot join
- Has history of life-threatening asthma defined as an asthma episode(s) that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s), within past 1 year or during run-in period
- Has history of any asthma-related hospitalizations within the past one year prior to screening visit (Visit 1) or during the run-in period
- Has history of any pulmonary disorder other than asthma, including but not limited to: diagnosis of chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, bronchiectasis, chronic bronchitis, pulmonary hypertension, active pulmonary tuberculosis, or pulmonary carcinoma.
- Has current evidence of bronchopulmonary dysplasia or pulmonary fibrosis
- Has recent respiratory tract infection that is not resolved within 4 weeks of screening and is considered significant in the opinion of the investigator
- Patients who, in the opinion of the investigator, significantly abuse alcohol or drugs, will be excluded.
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- Is taking any immunosuppressive medications within 4 weeks prior to the screening and during the study
- Use of systemic or oral corticosteroids within 2 months or intramuscular depot corticosteroid treatment 90 days prior to the screening or during the run-in period for any reason other than asthma.
- Women of childbearing potential who are lactating or pregnant at screening visit, as documented by a positive screening pregnancy test.
- Has previously been randomized in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Randomized Parallel-Group 6-Week Treatment Clinical Study to Assess BE of Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Comparison With Reference Product, Symbicort® in Adult Asthma Patients
The purpose of the study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in adult patient with Asthma
Read the detailed description
This study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measures at different timepoints in adult patient with Asthma.
- Conditions
- Asthma
- Being tested
- Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg, Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μgDrug
Also called Test product
Inhalation aerosol, 2 actuations orally inhaled twice daily
Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation AerosolDrug
Also called RLD
Inhalation aerosol, 2 actuations orally inhaled twice daily
PlaceboDrug
Also called Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg
Inhalation aerosol, 2 actuations orally inhaled twice daily
| Study group | Role | What they receive |
|---|---|---|
| Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg | Experimental | Inhalation Aerosol, 2 actuations orally inhaled twice daily Receives: Drug: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg |
| Symbicort® | Active comparator | Inhalation Aerosol, 2 actuations orally inhaled twice daily Receives: Drug: Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol |
| Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg | Placebo comparator | Inhalation Aerosol, 2 actuations orally inhaled twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serial Force Expiration volume1
Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the treatment
Measured: From time 0 to 12 hours
Change in FEV1 from baseline
FEV1 measured in the morning prior to the dosing of inhaled medication on the last day of the 6 weeks treatment
Measured: 6 weeks treatment
Secondary outcomes (4)
Number and Severity of Adverse Events and Serious Adverse Events
Assessment of No. of AEs, its severity, and relatedness and SAE.,
Measured: 6 weeks treatment
Assessment of vital signs: Pulse rate
Assessment of vital signs
Measured: 6 weeks treatment
Number of participants with suspected oral infection performed with an oropharyngeal examination
Assessment of physical examination including oropharyngeal examination
Measured: 6 weeks treatment
Assessment of vital signs: Systolic and diastolic Blood Pressures
Assessment of vital signs: Systolic and diastolic Blood Pressures
Measured: 6 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start15 Apr 2022
- Primary completion15 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cipla Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orlando Rivero, MD, Principal investigator, Global Research Solution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322707
- Sponsor's protocol ID
- CRD/20
- Status last verified
- Aug 2023
- First submitted
- 31 Mar 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Parallel-Group 6-Week Treatment Clinical Study to Assess BE of Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Comparison With Reference Product, Symbicort® in Adult Asthma Patients
- ClinicalTrials.gov ID
- NCT05322707
- Acronym / sponsor ID
- CRD/20
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,485 participants (actual)
- Lead sponsor
- Cipla Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in adult patient with Asthma
Detailed description
This study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measures at different timepoints in adult patient with Asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg | Experimental | Drug: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μgInhalation Aerosol, 2 actuations orally inhaled twice daily |
| Symbicort® | Active comparator | Drug: Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation AerosolInhalation Aerosol, 2 actuations orally inhaled twice daily |
| Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg | Placebo comparator | Drug: PlaceboInhalation Aerosol, 2 actuations orally inhaled twice daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients who are 18-70 years of age
- Has moderate-to-severe asthma with a pre-bronchodilator FEV1 of ≥45% and <80% of the predicted normal value for the patient after withholding bronchodilators
- Has ≥15% and ≥0.20 L reversibility of FEV1 within 30 minutes following administration of 360 μg of albuterol (pMDI)
- Is stable on current chronic asthma treatment (documented asthma diagnosis and/or prescription for asthma medications) for at least 4 weeks prior to screening visit (Visit 1).
- Has been diagnosed with asthma as defined by the National Asthma Education and Prevention Program (NAEPP 2007) at least 6 months prior to screening
Key exclusion criteria (10 listed)
- Has history of life-threatening asthma defined as an asthma episode(s) that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s), within past 1 year or during run-in period
- Has history of any asthma-related hospitalizations within the past one year prior to screening visit (Visit 1) or during the run-in period
- Has history of any pulmonary disorder other than asthma, including but not limited to: diagnosis of chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, bronchiectasis, chronic bronchitis, pulmonary hypertension, active pulmonary tuberculosis, or pulmonary carcinoma.
- Has current evidence of bronchopulmonary dysplasia or pulmonary fibrosis
- Has recent respiratory tract infection that is not resolved within 4 weeks of screening and is considered significant in the opinion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μgAlso: Test productInhalation aerosol, 2 actuations orally inhaled twice daily | Drug | Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg |
| Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation AerosolAlso: RLDInhalation aerosol, 2 actuations orally inhaled twice daily | Drug | Symbicort® |
| PlaceboAlso: Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μgInhalation aerosol, 2 actuations orally inhaled twice daily | Drug | Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg |
Primary outcome
Area under the serial Force Expiration volume1
Time frame: From time 0 to 12 hours
Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the treatment
Change in FEV1 from baseline
Time frame: 6 weeks treatment
FEV1 measured in the morning prior to the dosing of inhaled medication on the last day of the 6 weeks treatment
4 secondary outcomes
Number and Severity of Adverse Events and Serious Adverse Events
Time frame: 6 weeks treatment
Assessment of vital signs: Pulse rate
Time frame: 6 weeks treatment
Number of participants with suspected oral infection performed with an oropharyngeal examination
Time frame: 6 weeks treatment
Assessment of vital signs: Systolic and diastolic Blood Pressures
Time frame: 6 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orlando Rivero, MD principal investigator
Global Research Solution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg and Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol in people with Asthma, run by Cipla Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the serial Force Expiration volume1 (time frame: From time 0 to 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.