Dr Deborah Yates
Department of Thoracic Medicine
St Vincent’s Hospital, Sydney
In 2008 we started enrolling women with LAM for the Doxycycline in LAM trial at St Vincent’s Hospital, Sydney. The first stage of the trial commenced in November 2008. Three women completed the first treatment phase (with either doxycycline or placebo). The doxycyline was well tolerated and the study format is working well.
Four women are still in the middle of the three phase trial. Three others had to withdraw due to concomittant respiratory infections, as is to be expected. They had completed the first phase of the study. After a washout period to ensure there is no residual effect of their treatment for infection, they will repeat the second phase. Two women have withdrawn for practical reasons, not for reasons of toxicity. Another was taking doxycycline on open label and did not want to risk switching to a placebo. She has finished a course of the drug, but cannot be part of the study.
A further three will be starting the study soon. We have delayed starting them until our new nurse, Nicola, is fully initiated.
We are still enrolling women for the trial and keen to get more participants in the study.
Women interested in participating in the trial first have a screening visit at which we discuss the trial and obtain consent. Additional baseline tests follow including blood and urine tests, lung function tests, CT scans of the chest, a few non-invasive breath tests (exhaled breath condensate and exhaled nitric oxide) and a six minute walk test.
After a four week wash out period, women in the trial are randomly allocated one of the treatment arms of the study, which means either being on doxycycline for six months or taking a placebo (which is an inactive tablet). Neither the doctor nor the patient knows which tablet the participant is on until the study has finished. This means the effect of the doxycycline can be objectively compared with no treatment, for each patient.
When a woman agrees to participate in the study, she will be treated with a tablet (either doxycycline or placebo) for 6 consecutive months, followed by the alternative tablet. There is a 4 week gap between treatments during which time she is on no study medication to ensure the previous tablet is fully out of the system.
We review her at St.Vincents at three monthly intervals for the duration of the study. All the tests are repeated at each of these visits. In between these visits, she is encouraged to call us if she has any medical problems. Then we will arrange to see her at the hospital or arrange for her to be seen by her local doctor if more convenient.
If you have LAM, we encourage you to contact us and consider participating in this trial which we hope will contribute to a better understanding of LAM and may be useful in selection of future treatment.
If you have any questions about this trial, please contact Dr Deborah Yates at St Vincent’s Hospital (02) 83821111.