Clinical Efficacy Study of Salmeterol Xinafoate/Fluticasone Propionate in Asthma

March 28, 2017 updated by: Oriel Therapeutics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
879

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Subjects with a reliable clinical history of asthma documented at least 12 weeks prior to screening
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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)
  8. 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
  9. 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

  10. Subjects who are able and willing to give their written informed consent to participate in the study.

    **********************************************************

    Exclusion Criteria:

  11. Female Subjects who are pregnant or breastfeeding
  12. 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
  13. 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
  14. Subjects with a hypersensitivity to any sympathomimetic drug (e.g. Salmeterol or salbutamol/albuterol) or any inhaled, intranasal or systemic corticosteroid therapy
  15. 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)
  16. 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
  17. 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
  18. Subjects who have used any investigational drug in any clinical trial within 1 month of receiving the first dose of OT329 Solis™ study medication
  19. Subjects who cannot communicate reliably or who are unlikely to co-operate with the requirements of the study, in the opinion of the Investigator
  20. Subjects with a milk protein allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OT329 Solis
OT329 Solis (twice daily inhalation throughout the study)
Drug: OT329 (combination of fluticasone propionate and salmeterol xinafoate)
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler
Active Comparator: Advair Diskus
Advair Diskus (twice daily inhalation throughout the study)
Drug: Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate)
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler
Placebo Comparator: Placebo
Placebo (twice daily inhalation throughout the study)
Drug: Placebo
Placebo (lactose) administered via the Solis dry powder inhaler

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
0-12 hours after dosing on Day 1
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.
Post-4 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants With Adverse Events
Time Frame: From Screen (Day -28) until 1 week post last treatment
From Screen (Day -28) until 1 week post last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oriel Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rick Fuller, MD FRCP, Oriel Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OTT329/305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Results delayed pending FDA review/approval of drug.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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