Monitoring Intermittent vs Regular inhaled corticoSteroids in asthma: MIRSA study

Phase 4

• Conditions: Asthma; Respiratory - Asthma

• Registration Number: ACTRN12622000232730
• Lead Sponsor: Dr John D Brannan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-09
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

· Provision of informed consent
· Adults 18 years of age or older
· Physician diagnosis of asthma as mild disease as per GINA 2021 classification
· Symptomatic ACQ5 greater than 0.75
· Pre-bronchodilator FEV1 more than 80% of predicted
· AHR to mannitol at screening with a PD15 to mannitol of less than or equal to 155mg
· No ICS use for 1 month prior
· Willing and able to give informed consent for participation in the trial
· In the Investigator’s opinion, able and willing to comply with all trial requirements

Exclusion Criteria

· Participation in another clinical study
· Any asthma worsening requiring change in asthma treatment other than SABA within 30 days prior to Visit 1
· Use of oral, rectal or parenteral glucocorticosteroids (GCS) within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1
· Use of leukotriene receptor antagonists within 30 days prior to Visit 1
· Known or suspected hypersensitivity to study drugs or excipient
· Smoker (current or previous) with a smoking history of less than or equal to 10 pack years
· Use of any ß-blocking agent including eye-drops
· Medical history of life-threatening asthma including intubation and intensive care unit admission
· Hospital admission for asthma in the 12 months prior to Visit 1
· Other significant respiratory disease (COPD, bronchiectasis, lung cancer…)
· Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study
· Planned hospital stay
· Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
· Unwilling or unable to switch from current asthma treatment regimen
· Not ready to comply with required medication withholding times for Mannitol challenge testing
For randomisation at Visit 3, patients should not fulfil any of the following criteria:
· Use of 6 or more SABA ‘as needed’ inhalations per day for at least 4 days of run-in
· Any asthma worsening requiring change in asthma treatment other than inhaled SABA from Visit 1 until Visit 3 and/or requiring any asthma treatment other than run-in study medication from Visit 2 until randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified