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

Low Dose Methotrexate in Severe Chronic Asthma Clinical Trial

Official title:

Low-dose Methotrexate for Change in Global Initiative for Asthma Step 5 Medications in Chronic Severe Asthma: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02124226
• Other study ID #: METGINA-005
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2021
• Est. completion date: July 2022

Study information

• Verified date: September 2021
• Source: Universita degli Studi di Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients will be recruited from the accessible asthmatic patients lists of tertiary referral centers. All patients will meet the stringent diagnostic criteria for CSA, including the requirement for the regular use of Step 5 medications (i.e. oral prednisone and/or omalizumab). The experimental design of the proposed study will take the form of a double-blind parallel-randomized placebo-controlled trial consisting of a total of eight visits including run-in and run-out periods. Patients will be randomly allocated to receive either MTX or matched placebo once a week as add-on therapy to their existing medication after run-in. Physiological, laboratory and clinical assessments will be measured regularly throughout the study and compared with baseline assessments.

We expect that MTX will reduce Step 5 medications dosage in patients with CSA without compromising the overall disease control. Improvement in several indicators of asthma severity and control will be also investigated

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: July 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Asthma
• Low Dose Methotrexate in Severe Chronic Asthma

Intervention

Drug:
• Methotrexate
7.5 mg/week + folic acid the day after
• Placebo
matched placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universita degli Studi di Catania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At least 50% reduction in total dosage of GINA step 5 medications		80 weeks
Secondary	clinically significant changes in clinimetric scores		80 weeks