Asthma MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Advair Diskus 100/50
Product Name: ADVAIR DISKUS 100/50
Pharmaceutical Form: Inhalation powder
Sponsors
Oriel Therapeutics Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult males and females = 18 years with BMI 19 to 32 kg/m2 (inclusive) and a bodyweight = 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 must demonstrate = 15% reversibility (and a = 200 mL difference) from prebronchodilator FEV1 within 15 to 30 minutes of receiving up to 400 mcg salbutamol by MDI with spacer or up to 5 mg salbutamol by nebulizer at Screening. 4. Patients who if female, are not currently pregnant or breast feeding and are using medically acceptable methods of contraception. 5. Patients whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator. 6. Patients who are negative for HBsAg, hepatitis C antibody and HIV I and II test at screening. 7. Patients who are negative for drugs of abuse and alcohol tests at screening and admission. 8. Patients who are non-smokers for at least 3 months prior to screening. 9. Patients who have a =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 Seretide Accuhaler or Advair® Diskus®. 4. Patients who have a QTc of > 500 msec. 5. Patients who have a history of relevant drug hypersensitivity. 6. Patients who have a history of alcoholism. 7. Patients who have a history of drug abuse. 8. Patients receiving oral or parenteral corticosteroid treatment within 4 weeks of Randomization for exacerbation of their asthma or who have been intubated for ventilation in the past 5 years or are considered to have very severe asthma. 9. Patients who are currently taking inhibitors of CYP3A4 such as ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, or telethromycin. 10. 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 11. Patients who have a significant infection or known inflammatory process on screening. 12. Patients who have acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn). 13. Patients who have an acute respiratory infection such as influenza at the time of screening and/or admission. 14. Female patients who are pregnant, trying to become pregnant, breast feeding, or not using an acceptable method of contraception. 15. Patients who have used any investigational drug in any clinical trial within 3 months of receiving the last dose. 16. Patients who have received the last dose of IMP greater than 3 months ago but who are on extended follow-up requiring blood sampling. 17. Patients using medication, which in the opinion of the Investigator will affect the outcome of the study. 18. Patients who have donated and/or received any blood or blood products within the previous 3 months prior to first dosing (to review on a case by case basis). 19. Patients who cannot communicate reliably with the investigator. 20. Patients who are unlikely to co-operate with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To investigate the effects of Advair® 100 / 50 (1 puff, 2 puffs or 4 puffs) on blood potassium and heart rate as potential pharmacodynamic markers. Also to measure the pharmacokinetics of salmeterol administered as a combination dry powder in this study to allow for PK/PD interrelationship.;Main Objective: To establish a model of dose-dependent bronchodilation that will be used to establish the pharmacodynamic equivalency of the LABA component of new combination asthma drug treatments. The intention to better characterize the timecourse of bronchodilatory changes following a single treatment with 3 doses of Advair® 100 / 50 (1 puff, 2 puffs or 4 puffs; equivalent to 100/50, 200/100 and 400/200 mcg, fluticasone/salmeterol respectively).;Primary end point(s): To establish a model of dose-dependent bronchodilation that will be used to establish the pharmcodynamic equivalency of the LABA component of new combination of asthma drugs and to investigate the pharmacokinetics of salmeterol administered as a combination dry powder in this study to allow for investigation of PK/PD interrelationship treatments. | — |
Countries
United Kingdom
Outcome results
None listed