Induced Sputum Study (0000-065)
Condition: Asthma
MeSH terms: Asthma
Intervention: Comparator: fluticasone; Placebo
Intervention description: Two puffs, of 250 µg each, will be administered to each patient to obtain a 500-µg dose at each prespecified time point. A total of five (5) doses (500 µg) each of inhaled fluticasone will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.; Two puffs, of placebo, will be administered to each patient at each prespecified time point. A total of five (5) doses of placebo will be administered during the single blind run-in phase. and matching placebo will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The primary goals of this study will be to implement innovative processing and detection
      assays to qualify induced sputum measurements of markers of allergen-induced airway
      inflammation. The results of this study are intended to form a platform to be used in the
      clinical development of novel asthma therapeutics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a history of mild to moderate persistent allergic asthma for at least 6
             months with typical symptoms, including cough, wheezing, and shortness of breath, is
             clinically stable and has no history of recent respiratory tract infection within 3
             weeks of the start of the study

          -  Patient, aside history of asthma, is judged to be in good health based on medical
             history, physical examination, vital sign measurements, and laboratory safety tests.

          -  Patient is able to perform reproducible pulmonary function test.

          -  Patient has an allergic response to house dust mite allergen, demonstrates a positive
             early and late phase response to an inhaled allergen challenge (as defined by a
             bronchoconstrictive response)

          -  Patient is a nonsmoker for at least 12 months. Patients must have less than or equal
             to 10 pack years of smoking to be included. (10 pack years = one pack per day for 10
             years.) Patients who have discontinued smoking for at least 10 months may be enrolled
             at the discretion of the investigator

          -  Patient is willing to avoid strenuous physical activity (i.e., strenuous or
             unaccustomed weight lifting, running, bicycling, etc.) for 72 hours prior to each
             visit when laboratory safety tests are obtained and 48 hours prior to allergen
             challenge

        Exclusion Criteria:

          -  Patient has a history of any illness that, in the opinion of the study investigator,
             might confound the results of the study or poses additional risk to the patient by
             their participation in the study

          -  Patient has taken oral corticosteroids within 8 weeks or inhaled corticosteroids/nasal
             corticosteroids within 4 weeks of screening and/or during the study

          -  Patient has a history of stroke, chronic seizures, or major neurological disorder

          -  Patient has a history of clinically significant endocrine, gastrointestinal,
             cardiovascular, hematological, hepatic, immunological, renal, respiratory (other than
             asthma), or genitourinary abnormalities or diseases, or has a history of neoplastic
             disease

          -  Patient is unable to refrain from or anticipates the use of any medication other than
             the ones permitted in this study, including prescription and non-prescription drugs or
             herbal remedies prior to administration of the initial dose of study drug, throughout
             the study (including washout intervals between treatment periods), until the poststudy
             visit

          -  Patient consumes excessive amounts of alcohol, defined as greater than 3 glasses of
             alcoholic beverages per day or >21 drink equivalents per week.

          -  Patient consumes excessive amounts, defined as greater than 6 servings of coffee, tea,
             cola, or other caffeinated beverages per day