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

NCT02124226 | Unknown Phase 3 DMC

• 1 other identifier: METGINA-005
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Low Dose Methotrexate in Severe Chronic Asthma

Keywords

Chronic severe asthma, immunomodulation, methotrexate, steroids, omalizumab

Outcome Measures

Primary Outcomes (1)

• At least 50% reduction in total dosage of GINA step 5 medications

  80 weeks

Secondary Outcomes (1)

• clinically significant changes in clinimetric scores

  80 weeks

Study Arms (2)

Methotrexate

EXPERIMENTAL

Starting 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

Drug: Methotrexate

Matched placebo

PLACEBO COMPARATOR

Placebo pills

Drug: Placebo

Interventions

Methotrexate DRUG

7.5 mg/week + folic acid the day after

Also known as: Several brand names

Methotrexate

Placebo DRUG

matched placebo

Also known as: matched placebo

Matched placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with a diagnosis of CSA taking GINA Step 5 medications (i.e. regular OCS and/or omalizumab for a minimum of 6 months);
• failure in weaning patients completely from Step 5 medications during run-in;
• male and female individuals age 18 - 75 years;
• patients must be able to provide consent;

You may not qualify if:

• use of immunomodulatory therapies in the preceding 3 months;
• recent or current history of alcoholism;
• high liver enzyme levels (greater than 2.5 times the upper limit of the normal range);
• serum creatinine levels greater than 2.0 mg/dL
• acute illness within 15 days of study medication administration;
• leucopenia (below 3.0x109/L) and/or thrombocytopenia (below 100x109/L).
• pregnancy or planning to become pregnant;

Sponsors & Collaborators

• Universita degli Studi di Catania: lead

Related Publications (1)

• Polosa R, Bellinvia S, Caruso M, Emma R, Alamo A, Kowalski ML, Domingo C. Weekly low-dose methotrexate for reduction of Global Initiative for Asthma Step 5 treatment in severe refractory asthma: study protocol for a randomized controlled trial. Trials. 2014 Dec 18;15:492. doi: 10.1186/1745-6215-15-492.

  PMID: 25523634 DERIVED

MeSH Terms

Interventions

Methotrexate

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Riccardo Polosa, Full Professor

  Universita di Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: December 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09