AsthmaPhase 1NCT02260492

Clinical Efficacy Study of Salmeterol Xinafoate/Fluticasone Propionate in Asthma

A Phase 1 study testing OT329 (combination of fluticasone propionate and salmeterol xinafoate) and Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate) in people with Asthma, run by Oriel Therapeutics at 47 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a study to establish the equivalence of OT329 Solis and Advair Diskus when administered by inhalation in patients with asthma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: OT329 (combination of fluticasone propionate and salmeterol xinafoate) and Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 879 participants
Where: 47 sitesUnited States
Study dates: Sep 2014to Jul 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Males and females ≥ 18 years old of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control
Subjects with a reliable clinical history of asthma documented at least 12 weeks prior to screening
Subjects with a pre-bronchodilator FEV1 of > 40% and <85% of the predicted value during the screening visit and on the first day of treatment
Subjects who are currently non-smoking and have not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had < 10 pack-years of historical use
Subjects with > 15% reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI). Note: This test may be repeated on a different day if the patient fails the first attempt; and if the patient achieves at least 10% reversibility and the Investigator thinks that a second attempt is appropriate
Subjects who are able to discontinue their asthma medications (inhaled corticosteroids and long-acting beta agonists) during the run-in period and for the remainder of the study

Show all 10Show fewer

Subjects who are able to replace current short-acting beta 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)
Subjects who are able to continue the following medications without a significant adjustment of dosage, formulation, or 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 for 12 hours, twice-a-day controlled release forms of theophylline for 24 hours, once-a-day controlled-release forms of theophylline for 36 hours
Subjects who are 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 and parenteral corticosteroids for 1 month and oral short-acting beta agonists for 12 hours
Subjects who are able and willing to give their written informed consent to participate in the study.

Who cannot join

Female Subjects who are pregnant or breastfeeding
Subjects who have life-threatening asthma in the last 10 years, as defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within the past year or during the run-in period
Subjects with 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
Subjects with a hypersensitivity to any sympathomimetic drug (e.g. Salmeterol or salbutamol/albuterol) or any inhaled, intranasal or systemic corticosteroid therapy
Subjects who are on other medications with the potential to affect the course of asthma or to interact with sympathomimetic amines (e.g. beta blockers, oral decongestants, benzodiazepines, digitalis, phenothiazines, polycyclic antidepressants, monoamine oxidase inhibitors)
Subjects with a 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

Show all 10Show fewer

Subjects with any factors (e.g. infirmity, disability, or geographic location) that the investigator feel would likely limit the patient's compliance with the study protocol or scheduled clinic visits
Subjects who have used any investigational drug in any clinical trial within 1 month of receiving the first dose of OT329 Solis™ study medication
Subjects who cannot communicate reliably or who are unlikely to co-operate with the requirements of the study, in the opinion of the Investigator
Subjects with a milk protein allergy

Trial locations and contacts

47 sites in 1 country.

City, postcode or hospital

47 sites in 1 country

United States47 sites

Oriel Investigative Site
Albuquerque, New Mexico, 87108
Oriel Investigative Site
Anaheim, California, 92801
Oriel Investigative Site
Austin, Texas, 78750
Oriel Investigative Site
Austin, Texas, 78756
Oriel Investigative Site
Bellevue, Nebraska, 68123
Oriel Investigative Site
Centennial, Colorado, 80112
Oriel Investigative Site
Charlotte, North Carolina, 28277
Oriel Investigative Site
Cincinnati, Ohio, 45231
Oriel Investigative Site
Cincinnati, Ohio, 45242
Oriel Investigative Site
Clearwater, Florida, 33756
Oriel Investigative Site
Coral Gables, Florida, 33134
Oriel Investigative Site
Eugene, Oregon, 97401
Oriel Investigative Site
Goodyear, Arizona, 85395
Oriel Investigative Site
Homestead, Florida, 33030
Oriel Investigative Site
Houston, Texas, 77055
Oriel Investigative Site
Houston, Texas, 77099
Oriel Investigative Site
Iowa City, Iowa, 52240
Oriel Investigative Site
Jupiter, Florida, 33458
Oriel Investigative Site
Kissimee, Florida, 34741
Oriel Investigative Site
Lawrenceville, Georgia, 30046
Oriel Investigative Site
Los Angeles, California, 90017
Oriel Invetigative Site
Los Angeles, California, 90048
Oriel Investigative Site
Medford, Oregon, 97504
Oriel Investigative Site
Miami, Florida, 33165
Oriel Investigative Site
Middleburg Heights, Ohio, 44130
Oriel Therapeutics Site
Minneapolis, Minnesota, 55402
Oriel Investigative Site
Mission Viejo, California, 92691
Oriel Investigative Site
New Port Richie, Florida, 34652
Oriel Investigative Site
New York, New York, 10018
Oriel Investigative Site
North Dartmouth, Massachusetts, 02747
Oriel Investigative Site
Oklahoma City, Oklahoma, 73120
Oriel Investigative Site
Omaha, Nebraska, 68114
Oriel Investigative Site
Orlando, Florida, 32806
Oriel Investigative Site
Plano, Texas, 75093
Oriel Investigative Site
Portland, Oregon, 97202
Oriel Investigative Site
Providence, Rhode Island, 02906
Oriel Investigative Site
Raleigh, North Carolina, 27607
Oriel Investigative Site
Richmond, Virginia, 23229
Oriel Investigative Site
Rock Hill, South Carolina, 29732
Oriel Investigative Site
Skillman, New Jersey, 08558
Oriel Investigative Site
St Louis, Missouri, 63141
Oriel Investigative Site
Tacoma, Washington, 98405
Oriel Investigative Site
Tallahassee, Florida, 32308
Oriel Investigative Site
Tempe, Arizona, 85283
Oriel Investigative Site
Toledo, Ohio, 43617
Oriel Investigative Site
Warwick, Rhode Island, 02886
Oriel Investigative Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Clinical Endpoint Study of Salmeterol Xinafoate/Fluticasone Propionate Combination for Comparison of a Test and Reference Product in Patients With Asthma

This is a study to establish the equivalence of OT329 Solis and Advair Diskus when administered by inhalation in patients with asthma.

Conditions: Asthma
Being tested: OT329 (combination of fluticasone propionate and salmeterol xinafoate), Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate), Placebo
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OT329 (combination of fluticasone propionate and salmeterol xinafoate)Drug
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate)Drug
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler
PlaceboDrug
Placebo (lactose) administered via the Solis dry powder inhaler

Study groups in NCT02260492
Study group	Role	What they receive
OT329 Solis	Experimental	OT329 Solis (twice daily inhalation throughout the study) Receives: Drug: OT329 (combination of fluticasone propionate and salmeterol xinafoate)
Advair Diskus	Active comparator	Advair Diskus (twice daily inhalation throughout the study) Receives: Drug: Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate)
Placebo	Placebo comparator	Placebo (twice daily inhalation throughout the study) Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Serial FEV1-time Curve (AUC 0-12h)
Bioequivalence comparison of lung function (FEV1) for 12 hours after the first dose on Day 1 following OT329 Solis and Advair Diskus treatment. Serial lung function measurements were made pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose.
Measured: 0-12 hours after dosing on Day 1
FEV1 Trough
Bioequivalence comparison of trough lung function (FEV1) after 4 weeks of treatment with OT329 SOLIS or ADVAIR DISKUS.
Measured: Post-4 weeks of treatment

Secondary outcomes (1)

Number of Participants With Adverse Events
Measured: From Screen (Day -28) until 1 week post last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Jul 2015

First posted9 Oct 2014 (estimated)
Study startSep 2014
Primary completionMay 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 879 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02260492
Sponsor's protocol ID: OTT329/305
Status last verified: Mar 2017
First submitted: 6 Oct 2014
Last updated: 15 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Results delayed pending FDA review/approval of drug.

Publications

Longphre MV, Getz EB, Fuller R. Clinical Bioequivalence of OT329 SOLIS and ADVAIR DISKUS in Adults with Asthma. Ann Am Thorac Soc. 2017 Feb;14(2):182-189. doi: 10.1513/AnnalsATS.201606-436OC.
PubMed 27849125

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Endpoint Study of Salmeterol Xinafoate/Fluticasone Propionate Combination for Comparison of a Test and Reference Product in Patients With Asthma
ClinicalTrials.gov ID: NCT02260492
Acronym / sponsor ID: OTT329/305
Conditions: Asthma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 879 participants (actual)
Lead sponsor: Oriel TherapeuticsIndustry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: May 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 9 Oct 2014 (estimated)
Results: Posted 15 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a study to establish the equivalence of OT329 Solis and Advair Diskus when administered by inhalation in patients with asthma.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
OT329 Solis	Experimental	Drug: OT329 (combination of fluticasone propionate and salmeterol xinafoate)OT329 Solis (twice daily inhalation throughout the study)
Advair Diskus	Active comparator	Drug: Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate)Advair Diskus (twice daily inhalation throughout the study)
Placebo	Placebo comparator	Drug: PlaceboPlacebo (twice daily inhalation throughout the study)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Males and females ≥ 18 years old of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control
Subjects with a reliable clinical history of asthma documented at least 12 weeks prior to screening
Subjects with a pre-bronchodilator FEV1 of > 40% and <85% of the predicted value during the screening visit and on the first day of treatment
Subjects who are currently non-smoking and have not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had < 10 pack-years of historical use
Subjects with > 15% reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI). Note: This test may be repeated on a different day if the patient fails the first attempt; and if the patient achieves at least 10% reversibility and the Investigator thinks that a second attempt is appropriate

Key exclusion criteria (10 listed)

Female Subjects who are pregnant or breastfeeding
Subjects who have life-threatening asthma in the last 10 years, as defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within the past year or during the run-in period
Subjects with 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
Subjects with a hypersensitivity to any sympathomimetic drug (e.g. Salmeterol or salbutamol/albuterol) or any inhaled, intranasal or systemic corticosteroid therapy
Subjects who are on other medications with the potential to affect the course of asthma or to interact with sympathomimetic amines (e.g. beta blockers, oral decongestants, benzodiazepines, digitalis, phenothiazines, polycyclic antidepressants, monoamine oxidase inhibitors)

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
OT329 (combination of fluticasone propionate and salmeterol xinafoate)Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler	Drug	OT329 Solis
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate)Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler	Drug	Advair Diskus
PlaceboPlacebo (lactose) administered via the Solis dry powder inhaler	Drug	Placebo

Primary outcome

Area Under the Serial FEV1-time Curve (AUC 0-12h)
Time frame: 0-12 hours after dosing on Day 1
Bioequivalence comparison of lung function (FEV1) for 12 hours after the first dose on Day 1 following OT329 Solis and Advair Diskus treatment. Serial lung function measurements were made pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose.
FEV1 Trough
Time frame: Post-4 weeks of treatment
Bioequivalence comparison of trough lung function (FEV1) after 4 weeks of treatment with OT329 SOLIS or ADVAIR DISKUS.

1 secondary outcome

Number of Participants With Adverse Events
Time frame: From Screen (Day -28) until 1 week post last treatment

Results and safety

Results posted to the registry on 15 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OT329 Solis	418	395
Advair Diskus	419	406
Placebo	42	37

Primary outcome: Area Under the Serial FEV1-time Curve (AUC 0-12h)

Time frame: 0-12 hours after dosing on Day 1. Mean (Standard Deviation). Unit: Liters

Measure	OT329 Solis n = 418	Advair Diskus n = 419	Placebo n = 42
Value	29.610 (9.044)	30.151 (9.107)	27.270 (7.710)

OT329 Solis vs Advair Diskus: Test/Reference: 1.0799 (90% CI .8 to 1.25), p <0.05, ANCOVA

Population analysed: Intent-to-treat (ITT)

Primary outcome: FEV1 Trough

Time frame: Post-4 weeks of treatment. Mean (Standard Deviation). Unit: Liters

Measure	OT329 Solis n = 395	Advair Diskus n = 406	Placebo n = 37
Value	2.516 (0.792)	2.579 (0.774)	2.323 (0.736)

OT329 Solis vs Advair Diskus: Test/Reference: 1.0475 (90% CI .8 to 1.25), p <0.05, ANOVA

Population analysed: Intent-to-Treat

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from time of consent until 1 week post last treatment, up to 5 weeks. Adverse events from screen failed subjects are omitted.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OT329 Solis	0 of 417 (0%)	52 of 417 (12.5%)	0 of 417
Advair Diskus	2 of 419 (0.5%)	47 of 419 (11.2%)	1 of 419
Placebo	0 of 43 (0%)	7 of 43 (16.3%)	0 of 43

Limitations and caveats (from the sponsor): One patient was randomized to OT329 SOLIS treatment but was given a Placebo kit in error. They are included in the SOLIS group for the efficacy analysis and in the Placebo group for the safety analysis as dictated by the Statistical Analysis Plan.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27849125Longphre MV, Getz EB, Fuller R. Clinical Bioequivalence of OT329 SOLIS and ADVAIR DISKUS in Adults with Asthma. Ann Am Thorac Soc. 2017 Feb;14(2):182-189. doi: 10.1513/AnnalsATS.201606-436OC.
Individual participant dataSharing planned: Yes. Results delayed pending FDA review/approval of drug.

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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.

Rick Fuller, MD FRCP study director

Oriel Therapeutics

47 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 10 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 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites 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 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?

Yes. Results are posted in the registry (first posted 15 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 FEV1-time Curve (AUC 0-12h) (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?

On the ClinicalTrials.gov record for NCT02260492, 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 15 Jun 2017.