None listed
Conditions
Brief summary
This study is investigating if Tirzepatide (trade name Mounjaro) will improve asthma symptoms in obese patients with asthma and uncontrolled symptoms. This drugs causes weight loss using glucagon like peptide (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP); to make people feel fuller for longer. Patients will be enrolled in a prospective observational cohort trial stratified for metabolic syndrome. Although improvement in asthma control is the primary outcome, secondary outcome measures include changes in serum inflammatory markers. This is because its thought that obesity causes asthma by increasing background systemic inflammation. Inflammatory markers will be measured before during and after treatment with Tirzepatide looking to see how inflammation changes with therapy. The hypothesis is that obesity associated inflammation is correlated with poor asthma control and asthma control will improve with therapy alongside a reduction in serum systemic inflammatory markers.
Interventions
Tirzepatide 2.5mg administered subcutaneously weekly
First dose administered under supervision, all subsequent doses to be self-administered
Assessment for tolerability at 4 weeks
If no grade 2 or 3 side effects, then dose escalation by 2.5mg to;
5mg administered subcutaneously weekly
Assessment at 4 weeks as above
Dose escalation will occur in a similar fashion, every 4 weeks until a maximum dose of 10mg is achieved
Assessment of compliance completed monthly with either phone or face-to-face a
Tirzepatide 2.5mg administered subcutaneously weekly First dose administered under supervision, all subsequent doses to be self-administered Assessment for tolerability at 4 weeks If no grade 2 or 3 side effects, then dose escalation by 2.5mg to; 5mg administered subcutaneously weekly Assessment at 4 weeks as above Dose escalation will occur in a similar fashion, every 4 weeks until a maximum dose of 10mg is achieved Assessment of compliance completed monthly with either phone or face-to-face assessment. Trial participants will be asked directly regarding medical compliance. Any noncompliance will be recorded by the clinical trial officer. Total duration of treatment will be 36 weeks
Sponsors
Mater Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
All patients >16 years and over Physician diagnosed asthma Mild / moderate / severe Partially controlled asthma (ACQ6 > 0.75) BMI > 30 Able and willing to consent Speak and understand English Be able to attend study appointments Agree to have blood tests, lung function, participate in questionnaires and food diary Willing for us to access their smart devices for activity assessment Willing to use contraception if women of childbearing age Being treated with optimised guideline based conventional asthma care as per global initiative for asthma guidelines (GINA) Can be on all standard of care asthma treatment including advanced therapies Stratification for metabolic syndrome
Exclusion criteria
Exclusion criteria Unable / unwilling to consent Currently using a glucagon like peptide - one (GLP-1) agonist Regular use of illicit substances Contraindication or intolerance to glucagon like peptide - one (GLP-1) agonists treatment in the past Specific for glucagon like peptide - one (GLP-1) agonists Patients with type 1 diabetes Taking insulin for type 2 diabetes mellitus (T2DM) Taking sulphonylurea History of acute pancreatitis Pregnancy or plans of becoming pregnant
Outcome results
None listed