Preliminary Study of Dornase Alfa to Treat Chest Infections Post Lung Transplant.
Status:
Completed
Trial end date:
2017-08-23
Target enrollment:
Participant gender:
Summary
Patients who have undergone lung transplantation are at an increased risk of developing chest
infections due to long-term medication suppressing the immune response. In other chronic lung
diseases such as cystic fibrosis (CF) and bronchiectasis, inhaled, nebulised mucolytic
medication such as dornase alfa and isotonic saline are often used as part of the management
of lung disease characterized by increased or retained secretions. These agents act by making
it easier to clear airway secretions, and are currently being used on a case-by-case basis
post lung transplantation.
To the investigators knowledge, these agents have not been evaluated via robust scientific
investigation when used post lung transplant, yet are widely used in routine practice.
Patients post lung transplant must be investigated separately as they exhibit differences in
physiology that make the clearance of sputum potentially more difficult when compared to
other lung diseases. Lower respiratory tract infections are a leading cause of hospital
re-admission post lung transplant. Therefore, this highlights the need for a randomized
controlled trial. The aim of this study is to assess the efficacy of dornase alfa, compared
to isotonic saline, in the management of lower respiratory tract infections post lung
transplant. Investigators hypothesize that dornase alfa will be more effective than isotonic
saline.
The effect of a daily dose of dornase alfa and isotonic saline will be compared over a
treatment period of 1 month. Patients admitted to hospital suffering from chest infections
characterized by sputum production post lung transplant will be eligible for study inclusion.
Patients will be followed up through to 3 months in total to analyze short-medium term
lasting effect. Investigators wish to monitor physiological change within the lung
non-invasively via lung function analysis whilst assessing patient perceived benefit via
cough specific quality of life questionnaires. These measures will be taken at study
inclusion and repeated after 1 month and 3 months. Day to day monitoring will be performed
via patient symptom diaries, incorporating hospital length of stay and exacerbation rate. The
outcomes of this study have the potential to guide clinical decision-making and highlight
safe and efficacious therapies.
Phase:
Phase 2
Details
Lead Sponsor:
The Alfred
Collaborators:
Dr Carey Denholm and Laura Denholm The Alfred Research Trusts Small Project Grant.