Health TrialsbyHealthPanel

Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)

ConditionsAsthma (Diagnosis)Persistent AsthmaModerate Asthma Exacerbation
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill

About this trial

In this single center, interventional pilot study, 40 participants at high risk for future exacerbation will be randomized to anakinra (v. placebo control) treatment for home administration as part of an asthma action plan (AAP) and monitored through their first moderate asthma exacerbation, triggering treatment dosing over a 26 week period. Key feasibility questions will be assessed in this pilot study to inform trial design and sample size selection for a future multi-site phase II clinical trial testing anakinra as a rescue treatment for moderate asthma exacerbations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Age ≥18 years

A history of physician-diagnosed persistent asthma or symptoms consistent with persistent asthma based on national or international guidelines for diagnosis and management of asthma.

Current use of controller therapy such as inhaled corticosteroid (ICS) or ICS in combination with long-acting beta agonist (LABA)

Disqualifiers

Physician diagnosis of other chronic pulmonary disease including cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema or congenital disorders of the lungs or airways.

History of undergoing bronchial thermoplasty.

Intubation for asthma in the last 12 months

History of malignancy except non-melanoma skin cancer within the last five years.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anakinra 100 Mg/0.67 Ml Inj Syringe

    Drug

    Active study treatment

  • Saline Placebo/0.67 Ml Inj Syringe

    Drug

    Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Active TreatmentActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Effect of Anakinra on absolute change in morning PEF from baseline during moderate asthma exacerbation

Area under the curve (AUC) of the absolute change from baseline, over the period of treatment day 1 through 10 days post-treatment day 1, calculated using the trapezoidal method, and comparing Anakinra to placebo treatment.

Time frame
Day 1 of treatment through day 10 after treatment
2

Study Design Feasibility - Percentage of participants who experience one moderate asthma exacerbation

Percent of randomized participants who experience one moderate asthma exacerbation (as defined by the participant's asthma action plan) during the 6-month study period.

Time frame
The 6-month period from randomization to the end of study visit

Secondary outcomes

1

Effect of Anakinra on Asthma Index during moderate asthma exacerbation

Asthma Index is a continuous variable that reflects the magnitude and timing of changes in asthma control. Asthma scores are calculated using objective peak expiratory flow (PEF) and subjective symptom score elements over a 48-hour period. Asthma scores will be calculated over the period of treatment day 1 through 10 days post-treatment day 1 and subtracted from the mean Asthma score from a stable baseline 7-day period to obtain the Asthma Index. The area under the curve (AUC) of the Asthma Index will be calculated over the period of treatment day 1 through 10 days post-treatment day 1. Higher Asthma Index AUC values represent a greater cumulative burden of uncontrolled asthma relative to the individual's stable baseline (i.e., worse asthma control), while lower values represent better-maintained asthma control over the assessment period.

Time frame
Day 1 of treatment to day 10 after treatment
2

Intervention Feasibility - Mean number of participants enrolled per month

Mean number of participants completing the screening visit and signing informed consent per month.

Time frame
18 months
3

Intervention Feasibility - Mean number of participants randomized per month

Mean number of participants completing the training and randomization visit per month.

Time frame
18 months
4

Intervention Feasibility - Percentage of participants retained through completion of study

Percentage of total randomized participants who complete visit 9 (end of study visit).

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: