Clinical Efficacy Study of Salmeterol Xinafoate/Fluticasone Propionate in Asthma
NCT ID: NCT02260492
Last Updated: 2017-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
879 participants
INTERVENTIONAL
2014-09-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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OT329 Solis
OT329 Solis (twice daily inhalation throughout the study)
OT329 (combination of fluticasone propionate and salmeterol xinafoate)
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler
Advair Diskus
Advair Diskus (twice daily inhalation throughout the study)
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
Placebo (twice daily inhalation throughout the study)
Placebo
Placebo (lactose) administered via the Solis dry powder inhaler
Interventions
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OT329 (combination of fluticasone propionate and salmeterol xinafoate)
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler
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
Placebo (lactose) administered via the Solis dry powder inhaler
Eligibility Criteria
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Inclusion Criteria
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.
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Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Oriel Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Rick Fuller, MD FRCP
Role: STUDY_DIRECTOR
Oriel Therapeutics
Locations
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Oriel Investigative Site
Goodyear, Arizona, United States
Oriel Investigative Site
Tempe, Arizona, United States
Oriel Investigative Site
Anaheim, California, United States
Oriel Investigative Site
Los Angeles, California, United States
Oriel Invetigative Site
Los Angeles, California, United States
Oriel Investigative Site
Mission Viejo, California, United States
Oriel Investigative Site
Centennial, Colorado, United States
Oriel Investigative Site
Clearwater, Florida, United States
Oriel Investigative Site
Coral Gables, Florida, United States
Oriel Investigative Site
Homestead, Florida, United States
Oriel Investigative Site
Jupiter, Florida, United States
Oriel Investigative Site
Kissimee, Florida, United States
Oriel Investigative Site
Miami, Florida, United States
Oriel Investigative Site
New Port Richie, Florida, United States
Oriel Investigative Site
Orlando, Florida, United States
Oriel Investigative Site
Tallahassee, Florida, United States
Oriel Investigative Site
Lawrenceville, Georgia, United States
Oriel Investigative Site
Iowa City, Iowa, United States
Oriel Investigative Site
North Dartmouth, Massachusetts, United States
Oriel Therapeutics Site
Minneapolis, Minnesota, United States
Oriel Investigative Site
St Louis, Missouri, United States
Oriel Investigative Site
Bellevue, Nebraska, United States
Oriel Investigative Site
Omaha, Nebraska, United States
Oriel Investigative Site
Skillman, New Jersey, United States
Oriel Investigative Site
Albuquerque, New Mexico, United States
Oriel Investigative Site
New York, New York, United States
Oriel Investigative Site
Charlotte, North Carolina, United States
Oriel Investigative Site
Raleigh, North Carolina, United States
Oriel Investigative Site
Winston-Salem, North Carolina, United States
Oriel Investigative Site
Cincinnati, Ohio, United States
Oriel Investigative Site
Cincinnati, Ohio, United States
Oriel Investigative Site
Middleburg Heights, Ohio, United States
Oriel Investigative Site
Toledo, Ohio, United States
Oriel Investigative Site
Oklahoma City, Oklahoma, United States
Oriel Investigative Site
Eugene, Oregon, United States
Oriel Investigative Site
Medford, Oregon, United States
Oriel Investigative Site
Portland, Oregon, United States
Oriel Investigative Site
Providence, Rhode Island, United States
Oriel Investigative Site
Warwick, Rhode Island, United States
Oriel Investigative Site
Rock Hill, South Carolina, United States
Oriel Investigative Site
Austin, Texas, United States
Oriel Investigative Site
Austin, Texas, United States
Oriel Investigative Site
Houston, Texas, United States
Oriel Investigative Site
Houston, Texas, United States
Oriel Investigative Site
Plano, Texas, United States
Oriel Investigative Site
Richmond, Virginia, United States
Oriel Investigative Site
Tacoma, Washington, United States
Countries
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References
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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.
Other Identifiers
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OTT329/305
Identifier Type: -
Identifier Source: org_study_id
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