Mild to Moderate AsthmaPhase 1NCT02266927
A Study to Compare the Bioavailability Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE™ FLUTICASONE With 440 µg of Flovent® HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2)
A Phase 1 study testing Flovent HFA and OPTINOSE™ FLUTICASONE in people with Mild to Moderate Asthma, run by Optinose US Inc. at 1 site in Ireland.
Trial summary
To compare the systemic exposure of a single dose of 400 µg of OPTINOSE FLUTICASONE with 440 µg of Flovent® HFA (fluticasone propionate) Inhalation Aerosol in asthmatic subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Mild to Moderate Asthma
- What is being tested?
- Flovent HFA and OPTINOSE™ FLUTICASONE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIreland
- Study dates
- Sep 2014to Apr 2015
- Phase
- Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects' ages 18 to 55 years, inclusive, at screening.
- Have a body mass index of 18 to 32 kg/m2, inclusive, and a body weight of not less than 52 kg for males and 45 kg for females.
- Otherwise healthy mild to moderate asthmatic (Part 2) with no clinically relevant abnormalities in the opinion of the Investigator as determined by medical history, physical examination, blood chemistry, hematology (including complete blood count), serology, urinalysis, vital signs, and ECG performed at screening.
- History of mild to moderate asthma, diagnosed by a physician, which is well controlled at the present time (no history of sudden or severe asthma exacerbation in the past 12 months).
- Are unlikely to exacerbate during the study due to seasonal allergen exposure.
- Able to tolerate withdrawal of their medication for a required period of time.
Who cannot join
- Currently have or have a history of disease or dysfunction of the cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, musculoskeletal, or other body system that is clinically significant in the opinion of the Investigator.
- History of smoking or use of nicotine-containing substances within the previous 3 months before screening.
- Hypersensitivity to fluticasone propionate or any of the excipients found in OPTINOSETM FLUTICASONE or Flovent® HFA (for Part 2).
- History of extensive nasal and/or sinus surgery.
- Known nasal obstruction including allergic rhinitis, nasal septal deviations, polyposis, severe mucosal swelling, nasal ulcers, nasal trauma or any other reason.
- History of acute severe asthma attacks.
Show all 9Show fewer
- History of seasonal asthma exacerbation, in which case subjects should be outside the relevant allergen season.
- Have evidence of any chronic medical conditions other than asthma requiring prescription medications (e.g., hypertension or diabetes).
- Have used inhaled, intranasal, oral, or injectable corticosteroids within 4 weeks prior to dosing. Subjects should be on stable treatment for at least 1 month prior to withdrawal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, 2-Part, Randomized, Crossover Study to Compare the Bioavailability of Intranasal Administration of 200 and 400 µg of OPTINOSE™ FLUTICASONE With 400 µg of Flonase® (Fluticasone Propionate) Nasal Spray (Part 1), and Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE™ FLUTICASONE With 440 µg of Flovent® HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2) (Current Investigation is Part 2 Only)
To compare the systemic exposure of a single dose of 400 µg of OPTINOSE FLUTICASONE with 440 µg of Flovent® HFA (fluticasone propionate) Inhalation Aerosol in asthmatic subjects.
- Conditions
- Mild to Moderate Asthma
- Being tested
- Flovent HFA, OPTINOSE™ FLUTICASONE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flovent HFADrug
OPTINOSE™ FLUTICASONEDrug
| Study group | Role | What they receive |
|---|---|---|
| Flovent® HFA 440µg | Active comparator | Flovent® HFA (fluticasone propionate) Inhalation Aerosol 440 µg Receives: Drug: Flovent HFA |
| OPTINOSE™ FLUTICASONE 400µg intranasal | Experimental | OPTINOSE™ FLUTICASONE, single dose of 400 µg intranasally Receives: Drug: OPTINOSE™ FLUTICASONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of least-squares means of the ln transformed PK parameter AUC0-∞ is the primary endpoint.
Part 2
Measured: Pre-dose and at 0.167, 0.333, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 9, 12, 16, 24, and 36 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optinose US Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian J Stewart, BM, MRCGP, MFPM, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266927
- Sponsor's protocol ID
- OPN-FLU-1102
- Status last verified
- Feb 2016
- First submitted
- 7 Oct 2014
- Last updated
- 3 Feb 2016
- Results posted
- No
Publications
Messina JC, Offman E, Carothers JL, Mahmoud RA. A Randomized Comparison of the Pharmacokinetics and Bioavailability of Fluticasone Propionate Delivered via Xhance Exhalation Delivery System Versus Flonase Nasal Spray and Flovent HFA Inhalational Aerosol. Clin Ther. 2019 Nov;41(11):2343-2356. doi: 10.1016/j.clinthera.2019.09.013. Epub 2019 Nov 12.
PubMed 31732149
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, 2-Part, Randomized, Crossover Study to Compare the Bioavailability of Intranasal Administration of 200 and 400 µg of OPTINOSE™ FLUTICASONE With 400 µg of Flonase® (Fluticasone Propionate) Nasal Spray (Part 1), and Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE™ FLUTICASONE With 440 µg of Flovent® HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2) (Current Investigation is Part 2 Only)
- ClinicalTrials.gov ID
- NCT02266927
- Acronym / sponsor ID
- OPN-FLU-1102
- Conditions
- Mild to Moderate Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Optinose US Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 Oct 2014 (estimated)
- 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 systemic exposure of a single dose of 400 µg of OPTINOSE FLUTICASONE with 440 µg of Flovent® HFA (fluticasone propionate) Inhalation Aerosol in asthmatic subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flovent® HFA 440µg | Active comparator | Drug: Flovent HFAFlovent® HFA (fluticasone propionate) Inhalation Aerosol 440 µg |
| OPTINOSE™ FLUTICASONE 400µg intranasal | Experimental | Drug: OPTINOSE™ FLUTICASONEOPTINOSE™ FLUTICASONE, single dose of 400 µg intranasally |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female subjects' ages 18 to 55 years, inclusive, at screening.
- Have a body mass index of 18 to 32 kg/m2, inclusive, and a body weight of not less than 52 kg for males and 45 kg for females.
- Otherwise healthy mild to moderate asthmatic (Part 2) with no clinically relevant abnormalities in the opinion of the Investigator as determined by medical history, physical examination, blood chemistry, hematology (including complete blood count), serology, urinalysis, vital signs, and ECG performed at screening.
- History of mild to moderate asthma, diagnosed by a physician, which is well controlled at the present time (no history of sudden or severe asthma exacerbation in the past 12 months).
- Are unlikely to exacerbate during the study due to seasonal allergen exposure.
Key exclusion criteria (9 listed)
- Currently have or have a history of disease or dysfunction of the cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, musculoskeletal, or other body system that is clinically significant in the opinion of the Investigator.
- History of smoking or use of nicotine-containing substances within the previous 3 months before screening.
- Hypersensitivity to fluticasone propionate or any of the excipients found in OPTINOSETM FLUTICASONE or Flovent® HFA (for Part 2).
- History of extensive nasal and/or sinus surgery.
- Known nasal obstruction including allergic rhinitis, nasal septal deviations, polyposis, severe mucosal swelling, nasal ulcers, nasal trauma or any other reason.
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 |
|---|---|---|
| Flovent HFA | Drug | Flovent® HFA 440µg |
| OPTINOSE™ FLUTICASONE | Drug | OPTINOSE™ FLUTICASONE 400µg intranasal |
Primary outcome
The ratio of least-squares means of the ln transformed PK parameter AUC0-∞ is the primary endpoint.
Time frame: Pre-dose and at 0.167, 0.333, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 9, 12, 16, 24, and 36 hours after dosing
Part 2
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 3 Feb 2016.
- Derived from this study: PubMed 31732149Messina JC, Offman E, Carothers JL, Mahmoud RA. A Randomized Comparison of the Pharmacokinetics and Bioavailability of Fluticasone Propionate Delivered via Xhance Exhalation Delivery System Versus Flonase Nasal Spray and Flovent HFA Inhalational Aerosol. Clin Ther. 2019 Nov;41(11):2343-2356. doi: 10.1016/j.clinthera.2019.09.013. Epub 2019 Nov 12.
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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.
Adrian J Stewart, BM, MRCGP, MFPM principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flovent HFA and OPTINOSE™ FLUTICASONE in people with Mild to Moderate Asthma, run by Optinose US Inc. at 1 site in Ireland.
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 9 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 3 Feb 2016. 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 Ireland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The ratio of least-squares means of the ln transformed PK parameter AUC0-∞ is the primary endpoint. (time frame: Pre-dose and at 0.167, 0.333, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 9, 12, 16, 24, and 36 hours after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02266927, which also lists 1 linked publication.
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 3 Feb 2016.