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

Low Dose Methotrexate in Severe Chronic Asthma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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;

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Low Dose Methotrexate in Severe Chronic Asthma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Methotrexate7.5 mg/week + folic acid the day after

Drug:Placebomatched placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MethotrexateStarting dose of 7.5 mg/week + folic acid the day after for 3 weeks as add-on therapy to their existing medication. Study treatment dosage will be increased, the maintenance dose will be 10 mg/week + folic acid the day after for 27 weeks

Matched placeboPlacebo pills

Study Status

Not yet recruiting

Start Date: April 2018

Completed Date: July 2019

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: At least 50% reduction in total dosage of GINA step 5 medications

Secondary Outcome: clinically significant changes in clinimetric scores

Study sponsors, principal investigator, and references

Principal Investigator: Riccardo Polosa, Full Professor

Lead Sponsor: Universita degli Studi di Catania

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02124226

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