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Trial record 2 of 14 for:    polosa

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02124226
Recruitment Status : Not yet recruiting
First Posted : April 28, 2014
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Riccardo Polosa, Universita degli Studi di Catania

Tracking Information
First Submitted Date  ICMJE April 24, 2014
First Posted Date  ICMJE April 28, 2014
Last Update Posted Date April 23, 2019
Estimated Study Start Date  ICMJE April 2020
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2014)
At least 50% reduction in total dosage of GINA step 5 medications [ Time Frame: 80 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02124226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2014)
clinically significant changes in clinimetric scores [ Time Frame: 80 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-dose Methotrexate for Change in Global Initiative for Asthma Step 5 Medications in Chronic Severe Asthma
Official Title  ICMJE Low-dose Methotrexate for Change in Global Initiative for Asthma Step 5 Medications in Chronic Severe Asthma: a Randomized Controlled Trial
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.

Detailed 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Low Dose Methotrexate in Severe Chronic Asthma
Intervention  ICMJE
  • Drug: Methotrexate
    7.5 mg/week + folic acid the day after
    Other Name: Several brand names
  • Drug: Placebo
    matched placebo
    Other Name: matched placebo
Study Arms  ICMJE
  • Experimental: Methotrexate
    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
    Intervention: Drug: Methotrexate
  • Placebo Comparator: Matched placebo
    Placebo pills
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2014)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02124226
Other Study ID Numbers  ICMJE METGINA-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Riccardo Polosa, Universita degli Studi di Catania
Study Sponsor  ICMJE Universita degli Studi di Catania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Riccardo Polosa, Full Professor Universita di Catania
PRS Account Universita degli Studi di Catania
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP