The Clinical Effect of Monodisperse Fluticasone Propionate in Asthma

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

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• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborator: GlaxoSmithKline
• Treatments: Fluticasone

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.