AsthmaPhase 3NCT03879837
Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg
A Phase 3 study testing Fluticasone propionate pressurized metered dose inhaler and Flovent HFA pressurized metered dose inhaler in people with Asthma, run by Actavis Inc. at 1 site in United States.
Trial summary
A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects with Asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone propionate pressurized metered dose inhaler and Flovent HFA pressurized metered dose inhaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,902 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 9 Jul 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ≥18 and ≤75 years of age male or female subjects of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control.
- Body mass index (BMI) ≥18 and ≤45.
- Diagnosis of asthma, as defined by the NAEPP-EPR3 at least 12 months prior to Enrollment at Screening Visit 1a.
- Pre bronchodilator highest forced expiratory volume in 1 second (FEV1) ≥45% and ≤85% of predicted normal value at Screening Visit 1b and on the first day of treatment prior to randomization.
- Reversibility of airway obstruction ≥15% of FEV1 within 30 minutes of 360mcg albuterol inhalation (4 puffs).
- Subjects should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to Enrollment at Screening Visit 1a.
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- Currently non-smoking, defined as abstinence from all smoking, including marijuana and all tobacco products (i.e., e-cigarettes, cigarettes, cigars, pipe, ortobacco) within the past year, a negative cotinine screening test at Screening Visit 1b, and <10 pack years of historical use.
- Able to replace current short-acting β agonist (SABA) with study issued albuterol inhaler for use as needed for the duration of the study.
- Able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits.
- Able to withhold all inhaled long acting β agonists (LABA) 24 hours before Screening Visit 1b.
- Able to discontinue current asthma medications (e.g., inhaled corticosteroids[ICS], LABA, etc.) during the Run-in period and for remainder of the study.
- Able to comply with study procedures, including correct use of inhaler devices and home peak expiratory flow (PEF) device, and maintaining an electronic diary (eDiary).
- Willingness to give their written informed consent to participate in the study.
Who cannot join
- Life-threatening asthma, defined as a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations due to asthma within the past year prior to Enrollment, or during the Screening or Run-in period.
- History of significant respiratory disease other than asthma (e.g., chronic obstructive pulmonary disease [COPD], interstitial lung disease, chronic bronchitis, emphysema, etc.).
- 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, cardiovascular, endocrine, or other diseases 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 exacerbates during the study.
- Viral or bacterial, upper/lower respiratory tract infection (U/LRTI), or sinus, or middle ear infection within 4 weeks prior to Screening Visit 1b, during the Run-in period, or on the first day of treatment prior to randomization.
- Hypersensitivity to any sympathomimetic drug (e.g., albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy.
- Hypersensitivity to any of the ingredients of FP pMDI or Flovent HFA.
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- Subjects receiving β2 blockers, anti-arrhythmics, anti-depressants, and/or monoamine oxidase inhibitors within 4 weeks prior to Screening Visit 1b.
- Subjects who required systemic or oral corticosteroids (for any reason) within the past 6 months prior to Screening Visit 1b.
- Subjects receiving medications that are strong cytochrome P4503A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole) within 2 weeks prior to Screening Visit 1b.
- Subjects receiving any approved or investigational biological treatment for asthma (e.g., omalizumab, mepolizumab) within 6 months prior to Screening Visit 1b.
- Subjects with clinically relevant abnormal chemistry laboratory findings at Screening Visit 1b as assessed by the Investigator.
- Subjects with clinically significant electrocardiogram (ECG) findings at Screening Visit 1b as assessed by the Investigator and/or cardiologist.
- Subjects who have received any Investigational Product (IP) within 1 month prior to Screening Visit 1b and as described in the Washout Table in Appendix 1.
- Female subjects who are pregnant or breast feeding.
- Evidence of oral candidiasis at Screening or randomization, or history within 1year prior to Screening Visit 1b.
- Evidence or history of tuberculosis, hypercorticism, or adrenal suppression.
- Evidence or history within the 6 months prior to Screening Visit 1b of clinically relevant eye problems such as cataracts. Any previous diagnosis or treatment for ocular hypertension or glaucoma is exclusionary.
- Subjects with hyperbilirubinemia (defined as aspartate aminotransferase [AST] or alanine aminotransferase [ALT] ≥3 times the upper limit of the normal range [ULN], or bilirubin ≥2 times the ULN) or Hy's Law events.
- Evidence or history of drug or alcohol abuse in the 2 years prior to Enrollment at Screening Visit 1a or a positive drug or alcohol test at Screening Visit 1b.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects With Asthma
A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects with Asthma.
- Conditions
- Asthma
- Being tested
- Fluticasone propionate pressurized metered dose inhaler, Flovent HFA pressurized metered dose inhaler, Placebo pressurized metered dose inhaler
- Keywords
- Bioequivalence
- 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 pressurized metered dose inhalerDrug
110 mcg per actuation
Flovent HFA pressurized metered dose inhalerDrug
Also called Fluticasone propionate pressurized metered dose inhaler
110 mcg per actuation
Placebo pressurized metered dose inhalerDrug
no active content
| Study group | Role | What they receive |
|---|---|---|
| Investigational Test Product | Experimental | Fluticasone propionate pressurized metered dose inhaler, 110 mcg per actuation Receives: Drug: Fluticasone propionate pressurized metered dose inhaler |
| Reference Listed Drug | Active comparator | Flovent HFA pressurized metered dose inhaler, 110 mcg per actuation Receives: Drug: Flovent HFA pressurized metered dose inhaler |
| Placebo | Placebo comparator | Placebo pressurized metered dose inhaler, no active content Receives: Drug: Placebo pressurized metered dose inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in baseline adjusted morning pre-dose FEV1 from the time of treatment randomization to Week 4.
Measured: 4 weeks
Secondary outcomes (1)
Superiority over Placebo
To confirm the Test and Reference listed Drug products are statistically superior to placebo (p< 0.05) on the primary study endpoint.
Measured: Approximately 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start25 Mar 2019
- Primary completion28 May 2021
- Study completion9 Jul 2021
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,902 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879837
- Sponsor's protocol ID
- TPI-18-03
- Status last verified
- Aug 2021
- First submitted
- 15 Mar 2019
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects With Asthma
- ClinicalTrials.gov ID
- NCT03879837
- Acronym / sponsor ID
- TPI-18-03
- Conditions
- Asthma
- Keywords
- Bioequivalence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,902 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 19 Mar 2019 (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, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects with Asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational Test Product | Experimental | Drug: Fluticasone propionate pressurized metered dose inhalerFluticasone propionate pressurized metered dose inhaler, 110 mcg per actuation |
| Reference Listed Drug | Active comparator | Drug: Flovent HFA pressurized metered dose inhalerFlovent HFA pressurized metered dose inhaler, 110 mcg per actuation |
| Placebo | Placebo comparator | Drug: Placebo pressurized metered dose inhalerPlacebo pressurized metered dose inhaler, no active content |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult ≥18 and ≤75 years of age male or female subjects of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control.
- Body mass index (BMI) ≥18 and ≤45.
- Diagnosis of asthma, as defined by the NAEPP-EPR3 at least 12 months prior to Enrollment at Screening Visit 1a.
- Pre bronchodilator highest forced expiratory volume in 1 second (FEV1) ≥45% and ≤85% of predicted normal value at Screening Visit 1b and on the first day of treatment prior to randomization.
- Reversibility of airway obstruction ≥15% of FEV1 within 30 minutes of 360mcg albuterol inhalation (4 puffs).
Key exclusion criteria (19 listed)
- Life-threatening asthma, defined as a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations due to asthma within the past year prior to Enrollment, or during the Screening or Run-in period.
- History of significant respiratory disease other than asthma (e.g., chronic obstructive pulmonary disease [COPD], interstitial lung disease, chronic bronchitis, emphysema, etc.).
- 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, cardiovascular, endocrine, or other diseases 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 exacerbates during the study.
- Viral or bacterial, upper/lower respiratory tract infection (U/LRTI), or sinus, or middle ear infection within 4 weeks prior to Screening Visit 1b, during the Run-in period, or on the first day of treatment prior to randomization.
- Hypersensitivity to any sympathomimetic drug (e.g., albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy.
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 pressurized metered dose inhaler110 mcg per actuation | Drug | Investigational Test Product |
| Flovent HFA pressurized metered dose inhalerAlso: Fluticasone propionate pressurized metered dose inhaler110 mcg per actuation | Drug | Reference Listed Drug |
| Placebo pressurized metered dose inhalerno active content | Drug | Placebo |
Primary outcome
Mean change in baseline adjusted morning pre-dose FEV1 from the time of treatment randomization to Week 4.
Time frame: 4 weeks
1 secondary outcome
Superiority over Placebo
Time frame: Approximately 4 Weeks
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 1 Sep 2021.
- Individual participant dataSharing planned: No. Participant data will not be shared.
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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 Phase 3 study testing Fluticasone propionate pressurized metered dose inhaler and Flovent HFA pressurized metered dose inhaler in people with Asthma, run by Actavis Inc. 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 19 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 1 Sep 2021. 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?
Mean change in baseline adjusted morning pre-dose FEV1 from the time of treatment randomization to Week 4. (time frame: 4 weeks). 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 1 Sep 2021.