Mild asthma MedDRA version: 9.1 Level: LLT Classification code 10003555 Term: Asthma bronchial
Conditions
Interventions
Product Name: GW870086X Rotadisk
Product Code: GW870086X
Pharmaceutical Form: Inhalation powder
Current Sponsor code: GW870086X
Concentration unit: µg microgram(s)
Concentration type: equal
Concentrat
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male subjects between 18 and 65 years of age inclusive. 2. Male subjects must agree to use one of the contraception methods listed in Section 8 of the protocol. This criterion must be followed from the time of the first dose of study medication until 90-95 hours post-last dose. 3. BMI within the range 19.0 – 29.0 kg/m2. 4. Liver function tests (bilirubin, AST, ALT) within normal laboratory parameters at screening. 5. Documented history of bronchial asthma currently being treated only with intermittent short-acting beta -agonist therapy by inhalation. 6. Pre-bronchodilator FEV1 >65% of predicted at screening. 7. No history of smoking within 6 months of the start of the study, and with a total pack year history of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Past or present disease, which as judged by the investigator, may affect the outcome of this study. 2. Clinically significant abnormalities in safety laboratory analysis at screening. 3. Subject has known history of hypertension or is hypertensive at screening. 4. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication. 5. History of life-threatening asthma. 6. Administration of oral, injectable or dermal steroids within 4 weeks or intranasal and/or inhaled steroids within 2 week of the screening visit. 7. Unable to abstain from medication or supplements that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazol from screening and throughout the study. 8. Unable to use the DISKHALER and/or DISKUS device correctly. 9. History of being unable to tolerate or complete methacholine or allergen challenge tests. 10. If, after 2 concurrent administrations of saline during the allergen challenge at screening the subjects still have a fall in FEV1 of greater than 10%. 11. Subject is undergoing allergen desensitisation therapy. 12. Subjects who are kept due to regulatory or juridical order in an institution. 13. Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of treatment with repeat inhaled doses of GW870086X once daily for 13 days on the late asthmatic response (LAR) to inhaled allergen in mild asthmatic subjects compared with placebo;Primary end point(s): Late Asthmatic Response (LAR): minimum FEV1 between 4-10 hours after allergen challenge on Day 13 of each treatment period.;Secondary Objective: • To evaluate the effect of treatment with GW870086X on the early asthmatic response (EAR) after allergen challenge in mild asthmatic subjects • To assess the safety and tolerability of repeat inhaled doses of GW870086X • To evaluate the effect of treatment with repeat inhaled doses of GW870086X on lung function as measured by FEV1 • To evaluate the effect of treatment with repeat inhaled doses of GW870086X on exhaled NO • To evaluate the effect of treatment with GW870086X on bronchial hyperreactivity as measured by methacholine challenge • To evaluate the effect of GW870086X on induced sputum post allergen challenge | — |
Countries
Germany
Outcome results
None listed