Randomised Controlled Trial of the efficacy and safety of an ICS (Inhaled Corticosteroid)/LABA (long-acting beta agonist) reliever therapy regimen in asthma.

Phase 1

• Conditions: Asthma.; MedDRA version: 19.0 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: EUCTR2015-002384-42-GB
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-18
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 675

Inclusion Criteria

1. Adults aged 18 to 75 years.
2. Self-report of a doctor’s diagnosis of asthma with:
a. Self-reported use of a SABA on =2 occasions in the previous 4 weeks but on average =2 occasions per day in the previous 4 weeks, if there have been no severe exacerbations in the last 12 months, or
b. Self-reported use of a SABA on average =2 occasions per day in the previous 4 weeks, if there has been a history of a severe exacerbation in the last 12 months.
3. Willing and able to give informed consent for participation in the trial.
4. In the Investigator’s opinion, able and willing to comply with all trial requirements.
5. Willing to allow their General Practitioner and/ or consultant, if appropriate, to be notified of participation in the trial.

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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 175

Exclusion Criteria

1. Self-reported use of ICS, LABA, leukotriene receptor antagonist, theophylline, anticholinergic agent or cromone as regular maintenance therapy in the 3 months before potential study entry. Note nasal corticosteroid therapy is permitted.
2. Self-reported past admission to the Intensive Care Unit (ICU) with life-threatening asthma (patients at highest risk of adverse asthma outcomes).
3. Self-reported hospital admission for asthma in the 12 months before potential study entry (patients at highest risk of adverse asthma outcomes).
4. Self-reported treatment with oral prednisone in the six weeks before potential study entry, representing recent unstable asthma.
5. A home supply of prednisone for use in worsening asthma.
6. Self-reported diagnosis of COPD, bronchiectasis or interstitial lung disease.
7. Self-reported greater than 20 pack year smoking history, or onset of respiratory symptoms after the age of 40 years in current or ex-smokers with =10 pack year history.
8. Self-reported current pregnancy or breast feeding at the time of enrolment or planned pregnancy within the study period.
9. Self-reported congestive heart failure, unstable coronary artery disease, atrial fibrillation or other clinically significant cardiac disease.
10. Unwilling or unable to switch from current asthma treatment regimen.
11. Other illness(es) likely to compromise participant safety or impact on the feasibility of results, at the discretion of the investigator.
12. Self-report of participation in another research trial involving an investigational product, in the past 12 weeks.
13. An on treatment FEV1 =50% of predicted at Visit 1 (predicted values must be calculated using the Global Lung Function Initiative equations).
14. Any known or suspected contraindications to the Investigational Medicinal Products or excipients.

Study & Design

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