The Clinical Effect of Monodisperse Fluticasone Propionate in Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: 1.5 microns at 50mg; 6 microns at 50mg; Placebo Comparator; MDI FP
Intervention description: STAG generated monodisperse 1.5micron particles; STAG generated monodisperse 6 micron particles; No drug just solvent
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Monodisperse aerosols; Asthmatics; Pharmacokinetics; AMP Challenge; Multiple Breath Nitrogen Washout

Summary:

      The objective here is to determine that the efficiency of inhaled drug delivery can be
      improved by using a fine mist cloud of drug particles (as opposed to a coarse mist cloud of
      drug particles). This information will be valuable in designing new inhalers in order to
      improve their beneficial effects and reduce their side effects, by using the least possible
      drug dose to achieve a good patient response.

      .
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or females aged greater than 18 years with a documented history of reversible
             airways disease responding to beta2-adrenergic therapy.

          2. Asthmatic patients who are free from significant cardiac, gastrointestinal, hepatic,
             renal, haematological, neurological and psychiatric disease.

          3. Patients who are stabilized on 500 micrograms or less of inhaled beclomethasone
             dipropionate or alternative inhaled corticosteroid (budesonide or ciclesonide).

          4. Patients who are able and willing to give written informed consent to take part in the
             study

          5. Not taking any regular medication that is contraindicated in those about to receive
             fluitcasone propionate (as indicated in the British National Formularly); other than
             the oral contraceptive pill.

        Exclusion Criteria:

          1. Those requiring maintenance oral or parenteral corticosteroid therapy for their
             airways disease or patients who have ceased maintenance oral or parenteral
             corticosteroid therapy within the four weeks prior to visit 1

          2. Those requiring greater than 500 micrograms of inhaled beclomethasone dipropionate or
             alternative inhaled corticosteroid (budesonide or ciclesonide).

          3. Subjects that have received inhaled or intravenous fluticasone propionate in the last
             2 months.

          4. Those whose reversible airways obstruction has been unstable in the last four weeks
             (indicated by any change in their maintenance therapy).

          5. Those participants who have had a lower respiratory tract infection in the previous
             four weeks

          6. Those who have donated 450ml blood or more within the previous 1 month.

          7. Those who have a history of drug allergy which, in the opinion of the Unit Physician,
             contraindicates his/her participation in the study.

          8. Any female volunteer or females who are pregnant or lactating or are likely to become
             pregnant during the trial. Women of child-bearing potential may be included in the
             study if, in the opinion of the investigator, they are taking adequate contraceptive
             precautions.

          9. Participants with a known or suspected allergy to corticosteroids or any component of
             the formulations and/or Suspected hypersensitivity to inhaled corticosteroid (this
             will be asked directly at the screening visit).

         10. Any patient with a contraindication to taking an inhaled steroid and specifically FP,
             listed in the British National Formulary will not be entered into this study

         11. Those who have experienced an acute asthma exacerbation requiring emergency room
             treatment and/or hospitalisation within one month of visit 1.