A Pilot Pharmacodynamic/Pharmacokinetic Study of Fluticasone Propionate Administered as a Dry Powder in Patients with Asthma.

Oriel Therapeutics Inc0 sites30 target enrollmentJuly 9, 2010

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Adult males and females \= 18 years with BMI 19 to 30 kg/m2 (inclusive) and a body weight \= 50 kg.
•2\.Patients with a clinical diagnosis of mild to moderate asthma (defined as satisfying the Global Initiative in Asthma \[GINA] definition of asthma or has satisfied in the past and have a pre\-bronchodilator forced expiratory volume in 1 second (FEV1\) \>/\= 50% at Screening.
•3\.Patients with FENO levels at screening and Day 1 pre\-dose of \>/\= 50 ppb.
•4\.Patients who if female, are not currently pregnant or breast feeding and are using medically acceptable methods of contraception.
•5\.Patients receiving inhaled, oral or parenteral corticosteroid treatment within 4 weeks of Randomization or who have been intubated for ventilation in the past 5 years or are considered to have very severe asthma are excluded from the study.
•6\.Patients whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator.
•7\.Patients who are negative for HBsAg, hepatitis C antibody and HIV I and II test at screening.
•8\.Patients who are negative for drugs of abuse and alcohol tests at screening and admission.
•9\.Patients who are non\-smokers for at least 3 months prior to screening.
•10\.Patients who have a \< 10 pack\-year smoking history.

•1\.Patients who do not conform to the above inclusion criteria.
•2\.Patients who have a clinically relevant history or presence gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders which would preclude participation in the opinion of the Investigator.
•3\.Patients who have a clinically relevant medical or surgical history that would preclude the administration of inhaled corticosteroids as indicated in the patient information leaflet for Flixotide Accuhaler or Flovent Diskus.
•4\.Patients who have a history of relevant drug hypersensitivity.
•5\.Patients who have a history of alcoholism.
•6\.Patients who have a history of drug abuse.
•7\.Patients who have received steroid treatment in the prior month or are taking concomitant medications likely to interfere with FENO production.
•8\.Patients who are currently taking inhibitors of CYP3A4 such as ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, or telethromycin.
•9\.Patients who consume more than 28 units (male)/ 21 units (female) of alcohol a week. unit \= 1 (125 mL) glass of wine \= 1 measure of spirits \= ½ pint of beer
•10\.Patients who have a significant infection or known inflammatory process on screening.