AsthmaNCT03535870
Clinical Endpoint Bioequivalence Study of Fluticasone Propionate & Salmeterol Xinafoate (100μg/50μg)
A study testing Fluticasone propionate/salmeterol and Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder in people with Asthma, run by West-Ward Pharmaceutical at 1 site in United States.
Trial summary
A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects with Asthma Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone propionate/salmeterol and Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,556 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2018to 10 Sep 2019
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects must be 12 years of age or older.
- Females must not be of childbearing potential or if of childbearing potential, must commit to consistent use of a form of birth control which is medically effective, in the judgment of the investigator.
- Be able to provide written informed consent or, in the case of adolescents, informed assent in addition to an informed consent form (ICF) signed by the adolescent's parent(s) or legal guardian(s).
- Be current non-smokers and also may not have used tobacco products (e.g., cigarettes, e-cigarettes, cigars, pipe tobacco) within the year prior to Visit 1, and have 10 years or less (10 pack-years for cigarettes) of historical use.
- Have persistent asthma, as defined by the National Asthma Education and Prevention Program, for at least 12 weeks before Visit 1.
- FEV1 at Visit 1 (screening) and Visit 2 (randomization) of: ≥40% and ≤85% predicted normal value (for age ≥18 years), or ≥65% and ≤85% predicted normal value (for ages 12 to 17 years)
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- Demonstrate ≥15% reversibility of FEV1 between 10 and 30 minutes following 360 μg of albuterol inhalation. This may be demonstrated at the Screening Visit or anytime in the period leading up to Visit 2 (randomization).
- Be able to discontinue controller asthma medication (including LTM, inhaled corticosteroids [ICS] and long-acting β-agonists (LABAs]) during the Run-in Period and Treatment Period.
- Be able to replace current short-acting β-agonists (SABAs) with the study-supplied albuterol (or equivalent) rescue medication inhaler for use as needed for the duration of the study (subjects should be able to withhold all inhaled SABAs for a least 6 hours before lung function assessments during study visits).
- Must not have been treated (for any reason) with oral or parenteral corticosteroids for at least 1 month before Visit 1 and must not have used oral SABAs (not inhaled) for at least 12 hours before Visit 1 and for the remainder of the study. Use of oral/parenteral corticosteroids and oral SABAs is prohibited after Visit 1.
- Subjects may continue using short-acting forms of theophylline (withheld at least 12 hours before study visits), twice daily controlled-release forms of theophylline (withheld at least 24 hours before study visits), and once daily controlled-release forms of theophylline (withheld at least 36 hours before study visits). Subjects must be judged by the investigator as able to withhold these medications for the specified minimum time intervals before each site visit.
- Be able to answer questions regarding asthma status and be able to document device usage and asthma status on a twice daily basis.
- Demonstrate proper use of MDI and dry-powder inhaler devices.
Who cannot join
- Have a FEV1 reversibility of <15% at Visit 1.
- Are unable to discontinue ICS, LABA, or LTM.
- Have a history of life-threatening asthma, defined as an asthma episode (at any time in the past) associated with any of the following: respiratory arrest or intubation, hypercapnia, hypoxic seizures, or syncopal episode.
- Have a hospitalization within the year prior to Screening due to an asthma exacerbation.
- Have exercise-induced asthma as the only asthma-related diagnosis that does not require daily asthma control medicine.
- Have evidence or history of congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia.
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- Have evidence or history of any disease (hematologic, hepatic, neurologic, psychiatric, renal, or other) that in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
- Have any other relevant pulmonary disease except for asthma, including but not limited to chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, bronchiectasis, chronic bronchitis, emphysema, active pulmonary tuberculosis, pulmonary carcinoma, pulmonary fibrosis, or pulmonary hypertension.
- Have obstructive sleep apnea severe enough to warrant a prescription for biphasic or continuous positive-airway pressure therapy (BiPAP or CPAP), regardless of subject compliance with this therapy.
- Taking any of the following medications:
- Oral or parenteral beta blockers (excluding eye drops)
- Strong cytochrome P450 3A4 inhibitors
- Anti-IgE therapy, Xolair (omalizumab)
- Monoamine oxidase (MAO) Inhibitors
- Monoclonal antibodies/biologic agents which may affect the course of asthma (such as mepolizumab, reslizumab, lebrizumab, and others)
- Had a viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks before Screening (Visit 1), or have such an infection during the Run-in Period.
- Participated in an interventional study or used any investigational drug for any disease within 30 days (or 5 half-lives, if this is longer than 30 days) before Visit 1, or participated in this interventional study under the current protocol at any time previously.
- Are hypersensitive to any β2-agonist sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy or any component of these combination medications including severe milk protein hypersensitivity.
- Are exhibiting any factors (e.g., infirmity, disability, or geographic location, inability to follow instructions or study compliance requirements) that the investigator believes would likely limit the subject's compliance with the study protocol or scheduled site visits.
- Have an affiliation with the participating site; in other words, subject may not be an immediate family member of any study site staff and may not be employed directly or indirectly by the study site.
- Have a positive urine drug screen at Screening Visit.
- Have a positive urine cotinine screen at Screening Visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder Compared With Advair Diskus® 100/50 in Subjects With Asthma
A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects with Asthma
Read the detailed description
The primary objective of this study is to evaluate the clinical bioequivalence of generic fluticasone propionate 100 μg and salmeterol xinafoate 50 μg inhalation powder (test) to Advair Diskus ("Advair") 100/50 (reference) for the treatment of asthma.
The secondary objectives of the study are:
- To demonstrate statistical superiority of generic fluticasone propionate 100 μg and salmeterol xinafoate 50 μg inhalation powder to placebo.
- To demonstrate statistical superiority of Advair 100/50 to placebo.
- To investigate the safety and tolerability of fluticasone propionate 100 μg and salmeterol xinafoate 50 μg inhalation powder compared with Advair 100/50 in the target population
- Conditions
- Asthma
- Being tested
- Fluticasone propionate/salmeterol, Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder, Placebo
- 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/salmeterolDrug
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the LOMI inhaler device
Advair Diskus, 100 Mcg-50 Mcg Inhalation PowderDrug
Advair (Fixed dose combination of fluticasone propionate and salmeterol xinafoate administered via the Diskus inhaler device)
PlaceboDrug
placebo dry powder administered via the LOMI inhaler device
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone propionate/salmeterol | Experimental | fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) twice a day by inhalation throughout the study Receives: Drug: Fluticasone propionate/salmeterol |
| Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder | Active comparator | Advair Diskus (fluticasone propionate and salmeterol xinafoate) twice a day by inhalation throughout the study Receives: Drug: Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder |
| Placebo | Placebo comparator | placebo inhaled powder twice a day by inhalation throughout the study Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1-time curve (day 1)
Baseline-adjusted area under the serial FEV1-time curve calculated from time 0 (zero) to 12 hours on the first day of the Treatment Period
Measured: 24 hours
FEV1-time curve (day 28)
Baseline-adjusted, pre-dose FEV1 on the last day of the Treatment Period
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start26 Apr 2018
- Primary completion10 Sep 2019
- Study completion10 Sep 2019
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,556 participants (actual)
Sponsor and investigators
- Lead sponsor
- West-Ward Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535870
- Sponsor's protocol ID
- FLSA-P100/50-PVCL-2
- Status last verified
- Nov 2019
- First submitted
- 9 May 2018
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder Compared With Advair Diskus® 100/50 in Subjects With Asthma
- ClinicalTrials.gov ID
- NCT03535870
- Acronym / sponsor ID
- FLSA-P100/50-PVCL-2
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,556 participants (actual)
- Lead sponsor
- West-Ward PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 24 May 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.
A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects with Asthma
Detailed description
The primary objective of this study is to evaluate the clinical bioequivalence of generic fluticasone propionate 100 μg and salmeterol xinafoate 50 μg inhalation powder (test) to Advair Diskus ("Advair") 100/50 (reference) for the treatment of asthma.
The secondary objectives of the study are:
- To demonstrate statistical superiority of generic fluticasone propionate 100 μg and salmeterol xinafoate 50 μg inhalation powder to placebo.
- To demonstrate statistical superiority of Advair 100/50 to placebo.
- To investigate the safety and tolerability of fluticasone propionate 100 μg and salmeterol xinafoate 50 μg inhalation powder compared with Advair 100/50 in the target population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluticasone propionate/salmeterol | Experimental | Drug: Fluticasone propionate/salmeterolfluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) twice a day by inhalation throughout the study |
| Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder | Active comparator | Drug: Advair Diskus, 100 Mcg-50 Mcg Inhalation PowderAdvair Diskus (fluticasone propionate and salmeterol xinafoate) twice a day by inhalation throughout the study |
| Placebo | Placebo comparator | Drug: Placeboplacebo inhaled powder twice a day by inhalation throughout the study |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female subjects must be 12 years of age or older.
- Females must not be of childbearing potential or if of childbearing potential, must commit to consistent use of a form of birth control which is medically effective, in the judgment of the investigator.
- Be able to provide written informed consent or, in the case of adolescents, informed assent in addition to an informed consent form (ICF) signed by the adolescent's parent(s) or legal guardian(s).
- Be current non-smokers and also may not have used tobacco products (e.g., cigarettes, e-cigarettes, cigars, pipe tobacco) within the year prior to Visit 1, and have 10 years or less (10 pack-years for cigarettes) of historical use.
- Have persistent asthma, as defined by the National Asthma Education and Prevention Program, for at least 12 weeks before Visit 1.
Key exclusion criteria (22 listed)
- Have a FEV1 reversibility of <15% at Visit 1.
- Are unable to discontinue ICS, LABA, or LTM.
- Have a history of life-threatening asthma, defined as an asthma episode (at any time in the past) associated with any of the following: respiratory arrest or intubation, hypercapnia, hypoxic seizures, or syncopal episode.
- Have a hospitalization within the year prior to Screening due to an asthma exacerbation.
- Have exercise-induced asthma as the only asthma-related diagnosis that does not require daily asthma control medicine.
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/salmeterolFluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the LOMI inhaler device | Drug | Fluticasone propionate/salmeterol |
| Advair Diskus, 100 Mcg-50 Mcg Inhalation PowderAdvair (Fixed dose combination of fluticasone propionate and salmeterol xinafoate administered via the Diskus inhaler device) | Drug | Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder |
| Placeboplacebo dry powder administered via the LOMI inhaler device | Drug | Placebo |
Primary outcome
FEV1-time curve (day 1)
Time frame: 24 hours
Baseline-adjusted area under the serial FEV1-time curve calculated from time 0 (zero) to 12 hours on the first day of the Treatment Period
FEV1-time curve (day 28)
Time frame: 24 hours
Baseline-adjusted, pre-dose FEV1 on the last day of the Treatment Period
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 29 Nov 2019.
- 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.
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 study testing Fluticasone propionate/salmeterol and Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder in people with Asthma, run by West-Ward Pharmaceutical 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 13 inclusion and 22 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 29 Nov 2019. 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.
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?
FEV1-time curve (day 1) (time frame: 24 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 29 Nov 2019.