Clinical Efficacy Study of Salmeterol Xinafoate/Fluticasone Propionate in Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: OT329 (combination of fluticasone propionate and salmeterol xinafoate); Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate); Placebo
Intervention description: 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; Placebo (lactose) administered via the Solis dry powder inhaler
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 879.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility 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