Asthma MedDRA version: 12 Level: PT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Kepivance
Product Name: Kepivance
Pharmaceutical Form: Powder for solution for injection
Sponsors
Southampton Universities Hospital Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 - 60 years, either gender - Confirmed diagnosis of asthma for > 1 year as defined by BTS guidelines, requiring treatment with high dose inhaled corticosteroids +/- long acting beta2 agonists, with persisting symptoms requiring use of short-acting beta agonist therapy >3x/week. - Lifelong non-smoker or ex-smoker if patient has given up > 1yr previously and has a pack year history =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients requiring regular maintenance oral steroids for their asthma, or those who are adhering to symbicort SMART single inhaler regime - Pregnancy (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test >5mIU/ml), an intention to become pregnant or breast-feeding (lactating. - Subjects with active lung disease other than asthma - Significant medical (cardiopulmonary, neurological, renal, endocrine, gastrointestinal, psychiatric, hepatic or haematological)co-morbidity which in the view of the investigator could impact on the interpretation of results or participation in the trial, or which is uncontrolled with standard treatment. - Current participation in another clinical trial or previous participation within the last 12 weeks. - Alcohol or active drug abuse. - Ongoing allergen desensitisation therapy - Regular use of sedatives, hypnotics, tranquilisers - Cancer or previous history of cancer - Inability to understand directions for dosing and study assessment. - Inability to be contacted in case of emergency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical efffects of recombinant kgf (Palifermin), administered intravenously, on asthmatic patients. This will be assessed by looking at how 'twitchy', or 'reactive' their airways are before and after treatment, measured using a breathing test called 'PD15 Mannitol'.;Secondary Objective: - To measure the impact on clinical symptoms (as reported by the patient) and use of 'rescue' asthma medication (used to relieve symptoms of wheeziness), of intravenous recombinant kgf (Palifermin). - To assess the tolerability and safety of intravenous recombinant kgf (Palifermin) in asthmatic patients. - To document the effect of recombinant kgf (Palifermin) on cellular and radiological markers of epithelium permeability (the degree of 'leakiness' of the lining of the lung);Primary end point(s): Change in PD15 mannitol after treatment with recombinant human KGF | — |
Countries
United Kingdom
Outcome results
None listed