A double blind, randomised placebo controlled within patient cross-over study to assess the efficacy and safety of indacaterol (150 micrograms once daily) in the symptomatic treatment of pulmonary lymphangioleiomyomatosis (LAM)

Deborah H Yates0 sites15 target enrollmentNovember 14, 2013

Overview

No summary available.

Registry

who.int

Start Date

November 14, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

Female

Sponsor

Deborah H Yates

•1\.Age: 18\-80 inclusive.
•1\.2\.Diagnosed with LAM and classified into possible, probable and definite according to ERS criteria (1\).
•1\.3\.Willingness and ability to participate in the study after fully informed consent.
•1\.4\.Both sporadic LAM (sLAM) and TSC\-LAM (tuberous sclerosis\-related LAM) to be included.
•1\.5\.Women with all severity categories of LAM are eligible to participate in the study but those on continuous home oxygen will be excluded, as well as those not sufficiently well to participate in the requisite tests.

•1\. Known sensitivity to indacaterol or the class of long acting beta agonists
•2\. Patients with severe medical condition(s) which in the view of the investigator prohibit participation in the study (e.g. uncontrolled diabetes, uncontrolled heart failure, severe renal or liver disease, high blood pressure, coronary artery disease, cardiac arrhythmias, thyroid disorders, or lactose intolerance).
•3\. Use of any other investigational agent within the last 30 days
•4\. Current smoking or smoking within 6 months of study start.
•5\. Concurrent respiratory disease including a diagnosis of asthma (provided LAM has not been misdiagnosed as asthma prior to the diagnosis of LAM). Pleural pathology from previous pleurodeses and disease related to LAM are not included in this category.
•6\. Respiratory tract infection of exacerbation within the previous 4 weeks. Patients can be re\-entered into the trial after a 4 week recovery period, provided baseline FEV1 is within 10% of first study period.
•7\. Treatment with oral glucocorticosteroids within the previous 4 weeks.
•8\. Women of childbearing potential not using adequate contraceptive method(s) including the oral contraceptive pill, barrier contraception, IUD, as well as women who are breastfeeding.
•9\. Patients on continuous oxygen therapy.