Bronchial AsthmaPhase 3NCT03394989
BE Study of Fluticasone Propionate/Salmeterol Inhalation Powder in Asthma Patients
A Phase 3 study testing Fluticasone propionate/salmeterol 100/50 µg and Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT in people with Bronchial Asthma, run by Cipla Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in adult patients with asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Fluticasone propionate/salmeterol 100/50 µg and Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,366 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2018to 31 Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have signed informed consent form before initiation of any study related procedure.
- Male or female patients who are ≥18 years of age at the time informed consent is obtained.
- Documented diagnosis of asthma as defined by the National Asthma Education and Prevention Program (NAEPP) and diagnosed at least 12 weeks prior to screening.
- Patients with pre-bronchodilator forced expiratory volume in one second (FEV1) of 40% to 85% (both inclusive) of the predicted normal value at the Screening Visit V2.
- Patients who demonstrated an increase of ≥15% of FEV1 within 15 30 minutes following administration of albuterol at Screening Visit V2
- Patients who are stable on current asthma treatment for at least 4 weeks prior to Screening Visit V1.
Show all 12Show fewer
- Patients who are able to discontinue their current asthma medications (if any) and any other prohibited medications throughout the study, per the protocol list of prohibited medications during study participation (see Section 6.3.2).
- Patients who are able to replace their current short-acting beta 2 agonist (SABA) inhaler with the study provided albuterol inhaler to be used as rescue medicine (as needed) throughout the study. Patients who are able to withhold SABAs for at least 6 hours prior to lung function assessments on study visits.
- Patient who are non-smokers or ex-smokers; and have had ≤10 pack years
- Patients who have not inhaled tobacco or consumed other tobacco containing products have not inhaled vaping products, drugs of abuse, or inhaled marijuana for at least 12 months prior to screening.
- Women of childbearing potential (WOCBP) must not be lactating or pregnant at screening, as documented by a negative screening pregnancy test
- Women of childbearing potential must commit to consistent and correct use of an acceptable method of birth control (at the investigator's discretion) throughout the study.
Who cannot join
- History of life-threatening asthma defined as an asthma episode(s) that required intubation and/or was associated with hypercapnic, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s) within the past one year.
- History of any asthma-related hospitalizations within the past one year.
- Any asthma exacerbation requiring emergency room (ER) visits or systemic (including oral) corticosteroids within 2 months prior to signing the consent.
- Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia (prolonged QT interval as judged by the investigator). In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
- Patients with uncontrolled allergic rhinitis.
- Clinical visual evidence of oral candidiasis.
Show all 17Show fewer
- History of any adverse reaction; known hypersensitivity to any sympathomimetic drug
- Use of medication(s) with potential to affect the course of asthma or to interact with sympathomimetic amines throughout the study period.
- Recent viral or bacterial infection or infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 4 weeks of screening.
- Patients, who in the opinion of the investigator, significantly abuse alcohol or drugs will be excluded.
- Use of systemic (including oral) corticosteroids within 4 weeks or intramuscular depot corticosteroid treatment 90 days prior to screening for any reason other than asthma (see exclusion criteria #3 above).
- Patients taking any immunosuppressive medications within 4 weeks prior to screening and during the study.
- Factors (e.g., infirmity, disability, geographic location) that the investigator felt would likely limit the patients' compliance with the study protocol or scheduled clinic visits.
- Use of any investigational drug (approved or unapproved) within 30 days
- Study participation by clinical investigator site employees and/or their immediate relatives.
- Patients who are unable to produce valid and reproducible spirometry per American Thoracic Society/European Respiratory Society (ATS/ERS) standards at the screening visit or unable to use the electronic diary (e diary).
- Patients unable to use the inhalation powder device adequately.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Parallel-group, Placebo-controlled, 4-week Clinical Endpoint Bioequivalence Study Comparing Fluticasone Propionate/Salmeterol 100/50 µg Inhalation Powder With Advair® Diskus 100/50 µg in Asthma Patients
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in adult patients 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 measured at different time-points in adult patients with asthma.
- Conditions
- Bronchial Asthma
- Being tested
- Fluticasone propionate/salmeterol 100/50 µg, Placebo, Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionate/salmeterol 100/50 µgDrug
Test Arm: Dry powder inhaler
PlaceboOther
Placebo
Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUATDrug
Comparator Arm: Dry powder inhaler
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Fluticasone propionate/salmeterol 100/50 µg Receives: Drug: Fluticasone propionate/salmeterol 100/50 µg |
| Comparator | Active comparator | Fluticasone propionate/salmeterol 100/50 µg Receives: Drug: Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT |
| Placebo | Other | Test Placebo Receives: Other: 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 from time 0 to 12 hours (AUC0-12 hours)
Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the treatment
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start17 Oct 2018
- Primary completion3 Dec 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial 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
- Model description
- A multicenter, randomized, parallel-group, placebo-controlled
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cipla Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394989
- Sponsor's protocol ID
- U-FS-MU-AS3120
- Status last verified
- Nov 2019
- First submitted
- 26 Dec 2017
- Last updated
- 13 Aug 2020
- 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 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-group, Placebo-controlled, 4-week Clinical Endpoint Bioequivalence Study Comparing Fluticasone Propionate/Salmeterol 100/50 µg Inhalation Powder With Advair® Diskus 100/50 µg in Asthma Patients
- ClinicalTrials.gov ID
- NCT03394989
- Acronym / sponsor ID
- U-FS-MU-AS3120
- Conditions
- Bronchial Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,366 participants (actual)
- Lead sponsor
- Cipla Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 9 Jan 2018 (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 this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in adult patients with asthma.
Detailed description
This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points in adult patients with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A multicenter, randomized, parallel-group, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Fluticasone propionate/salmeterol 100/50 µgFluticasone propionate/salmeterol 100/50 µg |
| Comparator | Active comparator | Drug: Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUATFluticasone propionate/salmeterol 100/50 µg |
| Placebo | Other | Other: PlaceboTest Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who have signed informed consent form before initiation of any study related procedure.
- Male or female patients who are ≥18 years of age at the time informed consent is obtained.
- Documented diagnosis of asthma as defined by the National Asthma Education and Prevention Program (NAEPP) and diagnosed at least 12 weeks prior to screening.
- Patients with pre-bronchodilator forced expiratory volume in one second (FEV1) of 40% to 85% (both inclusive) of the predicted normal value at the Screening Visit V2.
- Patients who demonstrated an increase of ≥15% of FEV1 within 15 30 minutes following administration of albuterol at Screening Visit V2
Key exclusion criteria (17 listed)
- History of life-threatening asthma defined as an asthma episode(s) that required intubation and/or was associated with hypercapnic, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s) within the past one year.
- History of any asthma-related hospitalizations within the past one year.
- Any asthma exacerbation requiring emergency room (ER) visits or systemic (including oral) corticosteroids within 2 months prior to signing the consent.
- Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia (prolonged QT interval as judged by the investigator). In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
- Patients with uncontrolled allergic rhinitis.
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 |
|---|---|---|
| Fluticasone propionate/salmeterol 100/50 µgTest Arm: Dry powder inhaler | Drug | Test |
| PlaceboPlacebo | Other | Placebo |
| Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUATComparator Arm: Dry powder inhaler | Drug | Comparator |
Primary outcome
Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours)
Time frame: one day
Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the 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 13 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Bronchial Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fluticasone propionate/salmeterol 100/50 µg and Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT in people with Bronchial 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 12 inclusion and 17 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 13 Aug 2020. 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. 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 from time 0 to 12 hours (AUC0-12 hours) (time frame: one day). 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 13 Aug 2020.