Overview

Low-dose Methotrexate for Change in Global Initiative for Asthma Step 5 Medications in Chronic Severe Asthma

Status:
Not yet recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
All
Summary
Patients with chronic severe asthma (CSA) have a crippling disease and current available treatments are not satisfactory. Thus, management of CSA remains a major unmet need. Although the evidence from existing randomized controlled trials fails to support a definite role for immunomodulatory drugs in these patients due to major methodologic drawbacks, findings with low-dose methotrexate (MTX) are encouraging. However, larger and well designed clinical trials are required to establish the beneficial role of MTX in CSA and for the detection of the key characteristics of those who are going to respond to this drug. This study will be the first multi-centre RCT investigating the role of an add-on immunological modifier as a clinically useful therapeutic strategy in patients with well-phenotyped chronic severe asthma. As such, this study does not overlap with any other research currently ongoing.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Universita degli Studi di Catania
Treatments:
Methotrexate
Criteria
Inclusion Criteria:

1. patients with a diagnosis of CSA taking GINA Step 5 medications (i.e. regular OCS
and/or omalizumab for a minimum of 6 months);

2. failure in weaning patients completely from Step 5 medications during run-in;

3. male and female individuals age 18 - 75 years;

4. patients must be able to provide consent;

Exclusion Criteria:

1. use of immunomodulatory therapies in the preceding 3 months;

2. recent or current history of alcoholism;

3. high liver enzyme levels (greater than 2.5 times the upper limit of the normal range);

4. serum creatinine levels greater than 2.0 mg/dL

5. acute illness within 15 days of study medication administration;

6. leucopenia (below 3.0x109/L) and/or thrombocytopenia (below 100x109/L).

7. pregnancy or planning to become pregnant;