A Study to Assess Safety and Efficacy of a Novel Treatment, Keratinocyte Growth Factor (KGF), in Asthmatic Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01386151
• Date of registration: 24/06/2011
• Primary sponsor: University Hospital Southampton NHS Foundation Trust.
• Public title: A Study to Assess Safety and Efficacy of a Novel Treatment, Keratinocyte Growth Factor (KGF), in Asthmatic Patients
• Scientific title: Safety and Efficacy of Parenteral KGF in Moderate Asthmatic Subjects
• Date of first enrolment: August 2009
• Target sample size: 20
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01386151
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United Kingdom

Contacts

• Name: Peter H Howarth, BSc, MBBS, MRCP, FRCP

• Name: Peter H Howarth, BSc, MBBS
• Affiliation: Reader in Medicine and Honorary Consultant Physician, Southampton General Hospital

Key inclusion & exclusion 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 ß2 agonists, with
persisting symptoms requiring use of short-acting beta agonist therapy >3x/week.

- Never-smoker or ex-smoker, having stopped >1 year ago, with <10 pack year history.

- Subject must understand the procedures of the study and agree to participation in the
study by providing written informed consent

- Subject considered fit enough to undergo lung function testing including provocation
tests, and bronchoscopy.

- Subject must not be participating in another clinical trial or have done so within
the last 12 weeks.

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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bronchial Asthma

Intervention(s)

Drug: Keratinocyte Growth factor

Drug: Saline placebo

Primary Outcome(s)

Change in PD15 Mannitol [Time Frame: Baseline (7 days prior to drug), during drug administration period (3 days after first dose of drug), and short/intermediate term post drug period (3, 6 and 24 days after second drug administration)]

Secondary Outcome(s)

Adverse event reporting [Time Frame: Throughout study]

Change in asthma symptoms [Time Frame: ACQ is measured weekly during study. AQLQ is measured at baseline screening visit, and on day 35 (35 days post first administration of drug).]

Change in PC20 Metacholine [Time Frame: Baseline (6 days prior to drug) and short/intermediate term post drug period (7 and 25 days after second drug administration)]

Epithelial integrity/activation [Time Frame: Specimens are taken at 2 bronchoscopies, the first before the drug (4 days prior to the first drug administration) and the second after the drug (21 days after the first drug administration)]

Epithelial proliferation [Time Frame: Specimens are taken at 2 bronchoscopies, the first before the drug (4 days prior to the first drug administration) and the second after the drug (21 days after the first drug administration)]

Exhaled nitric Oxide [Time Frame: This is measured on the same days as PD15 mannitol, with an additional baseline measurement at the screening visit]

Short acting beta-agonist use/PEFR variability [Time Frame: Throughout study]

Secondary ID(s)

RHM MED 0879

Source(s) of Monetary Support

Please refer to primary and secondary sponsors