A Phase 1 Scintigraphy Study to Assess Nasal Deposition of Ciclesonide. Using a Novel Nasal Metered Dose Inhaler
Condition: Allergic Rhinitis (AR)
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: ciclesonide nasal aerosol; mometasone Aqueous (AQ) nasal spray
Intervention description: A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister; A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
Intervention MeSH terms: Mometasone Furoate; Ciclesonide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Ciclesonide; Allergic Rhinitis

Summary:

      This study is an open label, single dose, single site, randomized, cross over study that will
      assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide
      radiolabeled solution via a novel nasal Metered Dose Inhaler (MDI) and of a mometasone
      furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately 10-14
      patients with symptomatic allergic rhinitis, aged 18-65 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has give written informed consent and agrees to adhere to concomitant
             medication withholding periods, prior to participation.

          -  Patient is aged 18-65 years, inclusive.

          -  Patient has a Body Mass Index (BMI) of 18-30 kg/m2, inclusive

          -  Patient must be in general good health (defined as the absence of any clinically
             relevant abnormalities as determined by the Investigator) based on screening physical
             examination, medical history, and clinical laboratory values (Hematology, Chemistries
             and Urinalysis).

          -  A history of perennial or seasonal allergic rhinitis confirmed on GP report, or
             clinical diagnosis of perennial or seasonal allergic rhinitis confirmed at screening.

          -  A demonstrated sensitivity at the Screening visit, or within the 90 days prior to
             screening, to at least one allergen known to induce PAR (house dust mite, animal
             dander, cockroach, and molds) or SAR (grass pollen, tree pollen and weed pollen) using
             a 3 mm response to a standard skin prick test. The patient's positive allergen test
             must be consistent with the medical history of PAR/SAR.

          -  Must be willing and able to communicate and participate in the whole study.

          -  Patients must refrain from taking medication for allergic rhinitis, from Screening
             until completion of second dosing period.

          -  Patients, if female, must have a negative serum pregnancy test at screening. Females
             of childbearing potential must be instructed to and agree to avoid pregnancy during
             the study and must use an acceptable method of birth control:

               1. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive,
                  transdermal or injectable contraceptive for at least 1 month prior to entering
                  the study with continued use throughout the study and for thirty days following
                  study participation.

               2. Barrier method of contraception, eg, condom and/or diaphragm with spermicide
                  while participating in the study.

               3. True abstinence, when this is in line with the preferred and usual lifestyle of
                  the patient (if the patient is usually not sexually active but becomes active,
                  they with their partner, must use an acceptable method of birth control).

        Exclusion Criteria:

          -  Female patient who is pregnant or lactating.

          -  Patient has radiation exposure from clinical trials, including that from the present
             study, excluding background radiation but including diagnostic X rays and other
             medical exposures, exceeding 5 mSv in the last twelve months or 10 mSv in the last
             five years. No occupationally exposed worker, as defined in the Ionising Radiation
             Regulations 1999, shall participate in the study.

          -  Patient has an abnormality on physical examination that, in the investigator's
             opinion, would affect nasal airway resistance, including: nasal jewelry or piercings;
             nasal pathology such as nasal polyps or other clinically significant respiratory tract
             malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations.

          -  Patient has a history of cocaine or glue sniffing.

          -  Nasal surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within
             the last 60 days prior to the Screening visit.

          -  Patient is a smoker (based on results of breath carbon monoxide testing at screening;
             ie, ≥10 ppm).

          -  Active asthma requiring treatment with inhaled or systemic corticosteroids and/or
             routine use of beta agonists and any controller drugs (eg, theophylline, leukotriene
             antagonists, etc.); intermittent use (less than or equal to 3 uses per week) of
             inhaled short acting beta agonists is acceptable. Use of short acting beta agonists
             for exercise induced bronchospasm will be allowed.

          -  Patient has a history of any chronic respiratory disorder including active or
             quiescent pulmonary tuberculosis.

          -  Patient has a history of adverse reaction or allergy to ciclesonide, mometasone, other
             corticosteroids, or formulation excipients.

          -  Patient has a Screening forced expiratory volume (FEV1) <80% of the predicted value
             for their age, sex, height and race.

          -  Patient has had an upper respiratory tract infection (excluding otitis media) within
             14 days of first dosing period, or a lower respiratory tract infection within 3 months
             of the first study day.

          -  Previous participation in an intranasal ciclesonide HFA nasal aerosol study;
             participation in any investigational drug trial within the 60 days preceding the
             Screening visit or planned participation in another investigational drug trial at any
             time during this trial.

          -  History of alcohol or drug abuse within 2 years preceding the Screening visit.

          -  Study participation by clinical investigator site employees and/or their relatives or
             by more than one patient from the same household.

          -  Have any of the following conditions that are judged by the investigator to be
             clinically significant and/or affect the patients availability to participate in the
             clinical trial:

               -  impaired hepatic function including alcohol related liver disease or cirrhosis

               -  history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts

               -  any systemic infection including a history of a positive test for HIV, hepatitis
                  B or hepatitis C.

               -  hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus
                  or postmenopausal symptoms or hypothyroidism)

               -  gastrointestinal disease

               -  malignancy (excluding basal cell carcinoma)

               -  current neuropsychological condition with or without drug therapy

               -  Any condition that, in the judgment of the investigator, would preclude the
                  patient from completing the protocol with capture of the assessments as written.

               -  Regular alcohol consumption in males >21 units per week and females >14 units per
                  week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)