Clinical Efficacy Study of Salmeterol Xinafoate/Fluticasone Propionate in Asthma
Clinical Endpoint Study of Salmeterol Xinafoate/Fluticasone Propionate Combination for Comparison of a Test and Reference Product in Patients With Asthma
1 other identifier
interventional
879
1 country
47
Brief Summary
This is a study to establish the equivalence of OT329 Solis and Advair Diskus when administered by inhalation in patients with asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 asthma
Started Sep 2014
Typical duration for phase_1 asthma
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 6, 2014
CompletedFirst Posted
Study publicly available on registry
October 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
June 15, 2017
CompletedJune 15, 2017
March 1, 2017
8 months
October 6, 2014
February 10, 2017
March 28, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Post-4 weeks of treatment
Secondary Outcomes (1)
Number of Participants With Adverse Events
From Screen (Day -28) until 1 week post last treatment
Study Arms (3)
OT329 Solis
EXPERIMENTALOT329 Solis (twice daily inhalation throughout the study)
Advair Diskus
ACTIVE COMPARATORAdvair Diskus (twice daily inhalation throughout the study)
Placebo
PLACEBO COMPARATORPlacebo (twice daily inhalation throughout the study)
Interventions
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler
Eligibility Criteria
You may qualify if:
- 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
- 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.
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You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Oriel Investigative Site
Goodyear, Arizona, 85395, United States
Oriel Investigative Site
Tempe, Arizona, 85283, United States
Oriel Investigative Site
Anaheim, California, 92801, United States
Oriel Investigative Site
Los Angeles, California, 90017, United States
Oriel Invetigative Site
Los Angeles, California, 90048, United States
Oriel Investigative Site
Mission Viejo, California, 92691, United States
Oriel Investigative Site
Centennial, Colorado, 80112, United States
Oriel Investigative Site
Clearwater, Florida, 33756, United States
Oriel Investigative Site
Coral Gables, Florida, 33134, United States
Oriel Investigative Site
Homestead, Florida, 33030, United States
Oriel Investigative Site
Jupiter, Florida, 33458, United States
Oriel Investigative Site
Kissimee, Florida, 34741, United States
Oriel Investigative Site
Miami, Florida, 33165, United States
Oriel Investigative Site
New Port Richie, Florida, 34652, United States
Oriel Investigative Site
Orlando, Florida, 32806, United States
Oriel Investigative Site
Tallahassee, Florida, 32308, United States
Oriel Investigative Site
Lawrenceville, Georgia, 30046, United States
Oriel Investigative Site
Iowa City, Iowa, 52240, United States
Oriel Investigative Site
North Dartmouth, Massachusetts, 02747, United States
Oriel Therapeutics Site
Minneapolis, Minnesota, 55402, United States
Oriel Investigative Site
St Louis, Missouri, 63141, United States
Oriel Investigative Site
Bellevue, Nebraska, 68123, United States
Oriel Investigative Site
Omaha, Nebraska, 68114, United States
Oriel Investigative Site
Skillman, New Jersey, 08558, United States
Oriel Investigative Site
Albuquerque, New Mexico, 87108, United States
Oriel Investigative Site
New York, New York, 10018, United States
Oriel Investigative Site
Charlotte, North Carolina, 28277, United States
Oriel Investigative Site
Raleigh, North Carolina, 27607, United States
Oriel Investigative Site
Winston-Salem, North Carolina, 27103, United States
Oriel Investigative Site
Cincinnati, Ohio, 45231, United States
Oriel Investigative Site
Cincinnati, Ohio, 45242, United States
Oriel Investigative Site
Middleburg Heights, Ohio, 44130, United States
Oriel Investigative Site
Toledo, Ohio, 43617, United States
Oriel Investigative Site
Oklahoma City, Oklahoma, 73120, United States
Oriel Investigative Site
Eugene, Oregon, 97401, United States
Oriel Investigative Site
Medford, Oregon, 97504, United States
Oriel Investigative Site
Portland, Oregon, 97202, United States
Oriel Investigative Site
Providence, Rhode Island, 02906, United States
Oriel Investigative Site
Warwick, Rhode Island, 02886, United States
Oriel Investigative Site
Rock Hill, South Carolina, 29732, United States
Oriel Investigative Site
Austin, Texas, 78750, United States
Oriel Investigative Site
Austin, Texas, 78756, United States
Oriel Investigative Site
Houston, Texas, 77055, United States
Oriel Investigative Site
Houston, Texas, 77099, United States
Oriel Investigative Site
Plano, Texas, 75093, United States
Oriel Investigative Site
Richmond, Virginia, 23229, United States
Oriel Investigative Site
Tacoma, Washington, 98405, United States
Related Publications (1)
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.
PMID: 27849125DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Malinda Longphre PhD, Director Clinical Reserach
- Organization
- Oriel Therapeutics, a Novartis Company
Study Officials
- STUDY DIRECTOR
Rick Fuller, MD FRCP
Oriel Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2014
First Posted
October 9, 2014
Study Start
September 1, 2014
Primary Completion
May 1, 2015
Study Completion
July 1, 2015
Last Updated
June 15, 2017
Results First Posted
June 15, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Results delayed pending FDA review/approval of drug.