Monitoring inhaled corticosteroid efficacy in persons with asthma in pulmonary function laboratories.

Not Applicable

Active, not recruiting

• Conditions: Asthma; Respiratory - Asthma

• Registration Number: ACTRN12613000988752
• Lead Sponsor: Sydney Local Health District - Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Males and females age 18-75 years
-Pre-bronchodilator FEV1 greater than or equal to 70% of predicted and greater than 1L
-A positive response to mannitol challenge (PD15 of less than 635mg)
-Prescribed ICS treatment after initial challenge
-Non-smokers; ex-smokers with less than 10 pack years and no cigarettes within the last 12 months
ACQ score greater than 0.75

Exclusion Criteria

-Evidence of significant cardiovascular, haematological, hepatic, renal, neurological or psychiatric disease or any other major immunological or pulmonary disease other than asthma.
-Upper or lower respiratory tract infection within 2 weeks of the baseline visit, which may or may not have required a course of oral antibiotics
-Administration of an investigational drug in the preceding 4 months
-Subjects positive to mannitol that are being assessed as defence or police recruits

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma Control Questionnaire (ACQ) score[6, 12 and 18 weeks from baseline];The proportion of individuals with improved ACQ score (defined as a difference from baseline of greater than 0.5)[6, 12 and 18 weeks from baseline]

Secondary Outcome Measures

Name	Time	Method
Airway sensitivity to mannitol using the PD15; the provoking dose to cause a 15% fall in forced expiratory volume in one second (FEV1). Using the mannitol challenge bronchial provocation test.<br>[Measured at 18 weeks from baseline];Airway reactivity using the dose response ratio (RDR) which is calculated using the percentage fall on the final dose of mannitol divided by the cumulative dose of mannitol in mg. Using the mannitol challenge bronchial provocation test.[Measured 18 weeks from baseline];Asthma quality of life questionnaire (AQLQ) score<br>[Measrued at 6, 12 and 18 weeks from baseline];FEV1 (as percent predicted) measured using spirometry<br>[Measured at 6, 12 and 18 weeks from baseline];Airway reactance (Xrs) and airway resistance (Rrs) in kPa/l/sec using impulse oscillometry <br>[Measured at 6, 12 and 18 weeks from baseline];Exhaled nitric oxide (FeNO) in parts per billion using the Hypair nitric oxide analyser[Measured at 6, 12 and 18 weeks]