Rationale for therapy with low dose steroids combined with long-acting beta2-agonists in patients with allergic asthma: redirecting innate immune responses by long-term treatment with high doses of inhaled steroids

• Conditions: Asthma; MedDRA version: 9.1Level: LLTClassification code 10001705Term: Allergic asthma

• Registration Number: EUCTR2007-000097-23-NL
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria for entry into the run-in period:
1. Male or female subjects =18 years = 50 years
2. Allergic asthma: positive skin prick test for at least one aeroallergen or RAST
3. Documented history of asthma according to GINA guidelines for a period of at least 6 months
3. Subjects who have received regular treatment with FP at a dose of 250 mcg bd or equivalent with or without a LABA for at least 4 weeks before start of the run-in period, at a constant dose
4. Subjects with history of recurrent episodes of wheezing, breathlessness, chest tigthness and/or coughing in the previous year
5. Subjects who are able to use a DISKUS inhaler
6. Subjects who are able to perform reproducible lung function tests at Visit 1 (variation FEV1 smaller than 5% between the two best measurements)

Inclusion criteria for entry into the treatment period:
1. Subjects with an FEV1% of predicted bigger than 70%
2. ACT score smaller then 25 after the run-in period
3. Negative pregnancy urine test when of child bearing potential
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria for entry into the run-in period:
1. Subjects who have been hospitalised for their asthma within 4 weeks of visit 1
2. Subjects who had an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to visit 1
3. Subjects who received oral, parental, or depot corticosteroids within 4 weeks prior to visit 1
4. Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function
5. Subjects who hae received any investigational drugs within 4 weeks of visit 1
6. Subjects with a known or suspected hypersensitivity to inhaled steroids, beta2-agonists or lactose
7. Subjects who use any medication that significantly inhibits the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir, ketoconazole, itraconazole and erythromycin
8. Subjects who concurrently participate in another clinical study
9. Subjects who have previously been randomised in this study
10. Subjects who have currently smoke or subjects who smoked in the last 6 months prior to the study
11. Subjects with hepatic impairment or other significant disease.

Exclusion criteria for entry into the treatment period:
1. Any change in their run-in asthma medication
2. Non-compliance with the run-in medication (smaller than 70%)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified