EUCTR2008-002139-34-GB进行中（未招募）不适用
The Pharmacokinetics of Inhaled Fluticasone Propionate delivered as Monodisperse Aerosols - Pharmacokinetics of inhaled monodisperse Fluticasone Propionate
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Healthy Volunteers
- •Participants will be included if they meet all of the following inclusion criteria;
- •1) Healthy non smoking participants
- •2) Male or female aged above 18 years
- •3) No history of respiratory disease
- •4) Normal baseline spirometry as predicted for age, sex and height (we have excluded those with abnormal
- •spirometry as this may indicate an underlying lung condition that needs attention, and such participants will
- •be told their result and with their consent, the information will be forwarded to their General Practitioner, as
- •part of the safety and well being of the research participant.
- •5) No history of allergic disease i.e., a negative skin prick test
- •6) Participants who are free from significant cardiac, gastrointestinal, hepatic, renal, haematological,
- •neurological and psychiatric disease.
- •7) 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.
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Healthy Volunteers and Asthmatics
- •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) Female volunteers 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 Formularly 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.
研究者
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