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Clinical Efficacy Study of Salmeterol Xinafoate/Fluticasone Propionate in Asthma

Information source: Oriel Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: OT329 (combination of fluticasone propionate and salmeterol xinafoate) (Drug); Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate) (Drug); Placebo (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Oriel Therapeutics

Official(s) and/or principal investigator(s):
Rick Fuller, MD FRCP, Study Director, Affiliation: Oriel Therapeutics

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary outcome:

Area under the serial FEV1-time curve (AUC 0-12h)

FEV1 trough

Secondary outcome: Adverse Events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

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 45242, United States

Oriel Investigative Site, Cincinnati, Ohio 45231, 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

Additional Information

Starting date: September 2014
Last updated: April 28, 2015

Page last updated: August 23, 2015

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