Does the use of extra fine particle inhaled steroid (preventer) in asthma lead to improvements in asthma control?

Phase 1

• Conditions: Asthma; MedDRA version: 17.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-003923-39-GB
• Lead Sponsor: Tayside Medical Science Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-03
• Study Completion: 2018-06-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 74

Inclusion Criteria

Male and female volunteers aged 18-65, with persistent asthma.
Asthma Control Questionnaire score >1.0 (at end of run-in)
Spirometry: FEV1 >60% predicted.
Impulse oscillometry: R5>130% predicted and R5-R20>0.03kPa/L/s.
Ability to perform spirometry, IOS, bronchial challenge and all domiciliary measurements.
Ability to give informed consent.
Asthmatic patients receiving treatment at Step 2, 3, or 4 of BTS asthma guidelines.
Ability to withhold long acting beta 2 agonists for the duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 23
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Pregnancy or lactation.
Known or suspected sensitivity to the IMP(s).
Inability to comply with protocol.
Any clinically significant medical conditions that may either endanger the health or safety of the participant, or jeopardise the protocol.
An asthma exacerbation requiring systemic steroid therapy or lower respiratory tract infection requiring antibiotics within 3 months prior to study commencement.
Participation in previous trial within 30 days.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: We will also be examining how this change from standard to extra-fine particle size inhaled steroid affects other measures of lung function and the underlying inflammatory process of asthma.;Primary end point(s): Change in Asthma Control Questionnaire (ACQ) score from post-run-in baseline.;Timepoint(s) of evaluation of this end point: Baseline; visit 1 at 4 weeks; visit 2 at 8 weeks.;Main Objective: In this study we wish to study asthmatic patients who are not controlled on standard particle size inhaled steroids, in addition to having evidence of abnormal small airway function. By doing this we want to find out whether changing these patients to the same dose of an extra-fine particle inhaled steroid (instead of standard particle size) will improve asthma control by getting further into the lungs and improving small airway function.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Impulse oscillometry; Spirometry; blood ECP; blood eosinophils; FeNO; Mannitol PD15; OUCC; Mini-AQLQ; Domiciliary PEF, symptoms & reliever use.;<br> Timepoint(s) of evaluation of this end point: Domiciliary FEV1, symptoms and reliever use will be performed daily by the patient at home throughout the study.<br><br> Impulse oscillometry; Spirometry; blood ECP; blood eosinophils; FeNO; Mannitol PD15; OUCC; Mini-AQLQ will be performed at baseline, 4 weeks and 8 weeks.<br>