A study to assess the safety and the effects of using a growth factor, keratinocyte growth factor (KGF), in patients with moderate asthma
| ISRCTN | ISRCTN02767559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02767559 |
| Protocol serial number | BRU 3.1, Sponsor no. RHM MED 0879 |
| Sponsor | Southampton University Hospitals NHS Trust (UK) |
| Funder | Southampton General Hospital (UK) - Internal funding by Biomedical Research Unit |
- Submission date
- 16/06/2009
- Registration date
- 07/10/2009
- Last edited
- 24/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
IIR (RCMB) MP810
Level F, South Block
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| P.H.Howarth@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Safety and efficacy of parenteral keratinocyte growth factor (KGF) in moderate asthma subjects: a double-blind placebo-controlled randomised parallel group trial |
| Study objectives | That restoration of the bronchial epithelial barrier in asthma by treatment with KGF will reduce the responsiveness of the lungs to bronchoconstrictor agents, reduce airway inflammation and improve clinical disease expression. |
| Ethics approval(s) | Pending as of 17/06/2009 from the Southampton and South West Hampshire Local Research Ethics Committee (LREC) |
| Health condition(s) or problem(s) studied | Asthma |
| Intervention | The study population will be screened including medical history, examination, spirometry, diary card monitoring, exhaled nitric oxide measurement, skinprick testing, mannitol and metacholine provocation tests and baseline bronchoscopy. The intervention group will receive intravenous keratinocyte growth factor (KGF) in a 'collapsed dose' regime, at a dose of 180 µg/kg, given as an infusion on days 0 and day 11 of the trial. The control group will receive saline infusions. In between the doses and following the second doses the subjects will have further provocation tests and a further bronchoscopy. Subjects will be followed up for 36 days following the initial dose of the study drug/placebo. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Keratinocyte growth factor |
| Primary outcome measure(s) |
Change in provocative concentration in mannitol causing a 20% fall in FEV1 (PC20), measured in screening and on days 3, 14, 18 and 36 |
| Key secondary outcome measure(s) |
1. Asthma symptoms, assessed continuously during the trial |
| Completion date | 01/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Aged 18 - 50 years, either gender 2. Confirmed diagnosis of asthma for greater than 1 year as defined by British Thoracic Society (BTS) guidelines, requiring treatment with high dose inhaled corticosteroids in combination with long acting beta-2-agonists, with persisting symptoms requiring use of short-acting beta agonist therapy greater than 3 x/week 3. Lifelong non-smoker 4. Forced expiratory volume in one second (FEV1) greater than 40% 5. Subject must understand the procedures of the study and agree to participation in the study by providing written informed consent 6. Subject considered fit enough to undergo lung function testing including provocation tests, and bronchoscopy 7. Subject must not be participating in another clinical trial or have done so within the last 12 weeks |
| Key exclusion criteria | 1. Pregnancy (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin [hCG] laboratory test greater than 5 mIU/ml), an intention to become pregnant or breast-feeding (lactating) 2. Subjects with active lung disease other than asthma 3. 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 4. Current participation in another clinical trial or previous participation within the last 12 weeks 5. Alcohol or active drug abuse 6. Ongoing allergen desensitisation therapy 7. Regular use of sedatives, hypnotics, tranquilisers 8. Cancer or previous history of cancer 9. Inability to understand directions for dosing and study assessment 10. Inability to be contacted in case of emergency |
| Date of first enrolment | 01/08/2009 |
| Date of final enrolment | 01/11/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/05/2016: No publications found, verifying study status with principal investigator
