AsthmaPhase 3NCT03562923
A Study to Compare Fluticasone Propionate 100mcg/Salmeterol 50 mcg Inhalation Powder to Advair Discus 100/50
A Phase 3 study testing Test Product and Reference Product in people with Asthma, run by Amneal Ireland Limited.
Trial summary
To compare the efficacy and safety profiles of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder (test product) and ADVAIR DISKUS (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) (reference product) and to show that the efficacy of the 2 active products is superior to that… Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Test Product and Reference Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,204 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Jun 2019
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects (≥ 12 years of age) of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control.
- Diagnosed with asthma as defined by the National Asthma Education and Prevention Program (NAEPP) at least 12 weeks prior to screening.
- Pre-bronchodilator FEV1 of ≥40% and ≤85% of the predicted value during the screening visit and on the first day of treatment.
- Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had ≤ 10 pack-years of historical use.
- ≥15% reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI).
- Able to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for remainder of the study.
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- Able to replace current short-acting β agonists (SABAs) with salbutamol/albuterol inhaler for use as needed for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits).
- Able to continue the following medications without a significant adjustment of dosage, formulation, dosing interval for the duration of the study, and judged able by the investigator to withhold them for the specified minimum time intervals prior to each clinic visit:
- short-acting forms of theophylline 12 hours
- twice-a-day controlled-release forms of theophylline 24 hours
- once-a-day controlled-release forms of theophylline 36 hours
- Able to discontinue the following medications for the specified minimum time intervals prior to the run-in period and for the remainder of the study:
- oral corticosteroids 1 month
- parenteral corticosteroids 1 month
- oral short-acting β-agonists 12 hours
- Willingness to give their (and in the case of a minor their parent/guardian was able to give) written informed consent to participate in the study.
Who cannot join
- Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year or during the run-in period.
- Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. 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.
- Hypersensitivity to any sympathomimetic drug (e.g., salmeterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy.
- Medication(s) with the potential to affect the course of asthma or to interact with sympathomimetic amines, e.g.:
- β-blockers
- oral decongestants
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- benzodiazepines
- digitalis
- phenothiazines
- polycyclic antidepressants
- Monoamine oxidase inhibitors
- Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit or during the run-in period.
- Factors (e.g., infirmity, disability or geographic location) that the investigator felt would likely limit the patient's compliance with the study protocol or scheduled clinic visits.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Single Blind Placebo-Controlled Multi-Center Study Comparing Combination Therapy With Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder to Combination Therapy With ADVAIR DISKUS® 100/50 (Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder) in Treatment of Subjects With Asthma
To compare the efficacy and safety profiles of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder (test product) and ADVAIR DISKUS (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) (reference product) and to show that the efficacy of the 2 active products is superior to that of placebo in the treatment of subjects with asthma.
- Conditions
- Asthma
- Being tested
- Test Product, Reference Product, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test ProductDrug
Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder
Reference ProductDrug
Also called ADVAIR DISKUS
ADVAIR DISKUS® 100/50 (Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder)
PlaceboDrug
Placebo Product
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Test Product, 100/50 mcg, 2 x daily Receives: Drug: Test Product |
| Reference Product | Active comparator | Reference Product, 100/50 mcg, 2 x daily Receives: Drug: Reference Product |
| Placebo | Placebo comparator | Placebo Product 2 x daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-adjusted area under the serial FEV1-time curve
Baseline-adjusted area under the serial FEV1-time curve calculated from time zero to 12 hours (AUC0-12h) on the first day of treatment.
Measured: 0-12 hours after dosing on day 1
Baseline-adjusted, pre-dose FEV1
Baseline-adjusted, pre-dose FEV1 on the last day of a 4-week treatment
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study startOct 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionJun 2019 (estimated)
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
- Participant, Investigator
- Enrolment
- 1,204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amneal Ireland Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irshad Haque, Study director, Amneal Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562923
- Sponsor's protocol ID
- AI-FSX-001
- Status last verified
- Jun 2018
- First submitted
- 25 May 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single Blind Placebo-Controlled Multi-Center Study Comparing Combination Therapy With Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder to Combination Therapy With ADVAIR DISKUS® 100/50 (Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder) in Treatment of Subjects With Asthma
- ClinicalTrials.gov ID
- NCT03562923
- Acronym / sponsor ID
- AI-FSX-001
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,204 participants (estimated)
- Lead sponsor
- Amneal Ireland LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 20 Jun 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.
To compare the efficacy and safety profiles of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder (test product) and ADVAIR DISKUS (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) (reference product) and to show that the efficacy of the 2 active products is superior to that of placebo in the treatment of subjects with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Test ProductTest Product, 100/50 mcg, 2 x daily |
| Reference Product | Active comparator | Drug: Reference ProductReference Product, 100/50 mcg, 2 x daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Product 2 x daily |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female subjects (≥ 12 years of age) of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control.
- Diagnosed with asthma as defined by the National Asthma Education and Prevention Program (NAEPP) at least 12 weeks prior to screening.
- Pre-bronchodilator FEV1 of ≥40% and ≤85% of the predicted value during the screening visit and on the first day of treatment.
- Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had ≤ 10 pack-years of historical use.
- ≥15% reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI).
Key exclusion criteria (13 listed)
- Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year or during the run-in period.
- Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. 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.
- Hypersensitivity to any sympathomimetic drug (e.g., salmeterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy.
- Medication(s) with the potential to affect the course of asthma or to interact with sympathomimetic amines, e.g.:
- Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit or during the run-in period.
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 |
|---|---|---|
| Test ProductFluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder | Drug | Test Product |
| Reference ProductAlso: ADVAIR DISKUSADVAIR DISKUS® 100/50 (Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder) | Drug | Reference Product |
| PlaceboPlacebo Product | Drug | Placebo |
Primary outcome
Baseline-adjusted area under the serial FEV1-time curve
Time frame: 0-12 hours after dosing on day 1
Baseline-adjusted area under the serial FEV1-time curve calculated from time zero to 12 hours (AUC0-12h) on the first day of treatment.
Baseline-adjusted, pre-dose FEV1
Time frame: 4-weeks
Baseline-adjusted, pre-dose FEV1 on the last day of a 4-week treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
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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.
Irshad Haque study director
Amneal Pharmaceuticals, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Test Product and Reference Product in people with Asthma, run by Amneal Ireland Limited.
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 16 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irshad Haque (631-952-0214, ihaque@amneal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline-adjusted area under the serial FEV1-time curve (time frame: 0-12 hours after dosing on day 1). 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 20 Jun 2018.