Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000325303
Ethics application status
Approved
Date submitted
2/05/2008
Date registered
14/07/2008
Date last updated
14/07/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Doxycycline in Lymphanioleiomyomatosis (LAM): a randomised double blind placebo controlled crossover trial
Scientific title
Doxycycline in Lymphangioleiomyomatosis: a randomised double blind placebo controlled crossover trial to study the safety and efficacy of doxycycline on lung function, exercise capacity, quality of life indices and cyst size in patients with LAM
Secondary ID [1] 558 0
Clinical Trial Network (CTN) No 2007/269
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphangioleiomyomatosis 3102 0
Condition category
Condition code
Respiratory 3262 3262 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Doxycycline: 100mgs daily, oral for 6 months, washout period of 4 weeks between treatments
Intervention code [1] 2844 0
Treatment: Drugs
Comparator / control treatment
Placebo:methylcellulose 1 capsule daily, 6 months
Control group
Placebo

Outcomes
Primary outcome [1] 4152 0
Exercise capacity: 6 minute walk response
Timepoint [1] 4152 0
6 months, 1 year
Primary outcome [2] 4153 0
Change in quality of life and Visual Analogue Score (VAS) dyspnoea scores
Timepoint [2] 4153 0
6 months, 1 year
Primary outcome [3] 4154 0
Lung function: carbon monoxide diffusing capacity (DLCO), arterial blood gases, alveolar-arterial (A-a) gradient, total lung capacity (TLC), Residual volume (RV)/total lung capacity (TLC)
Change in size of lung cysts as assessed by a new automated computerised method.
Timepoint [3] 4154 0
6months, 1year
Secondary outcome [1] 6996 0
exhaled nitric oxide, exhaled breath condensate biomarkers, electronic nose (eNOSE) measurements
Timepoint [1] 6996 0
1 year
Secondary outcome [2] 6997 0
forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC)
Timepoint [2] 6997 0
1 year

Eligibility
Key inclusion criteria
a. Aged 18 or over
b. Informed signed consent
c. Diagnosis of pulmonary LAM as determined preferably by biopsy, or chest CT scan findings compatible with LAM.
d. Abnormal lung function i.e. compatible with LAM. There will be no FEV1 exclusion criterion
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Pregnancy or breast feeding
b. Inadequate contraception
c. Significant gastrointestinal disease such as to interfere with drug absorption, or predispose to severe reflux oesophagitis
d. Uncontrolled systemic disease
e. Significant renal impairment
f. Use of an investigational drug within the last 30 days.
g. Previous lung transplantation
h. Inability to attend scheduled clinic visits
i. Inability to give informed consent
j. Inability to perform pulmonary function testing
k. Chylous ascites sufficient to affect diaphragmatic function
l. Pleural effusion sufficient to blunt the costophrenic angle on a PA chest roentgenogram.
m. Acute pneumothorax within the past 2 months
n. Documented allergy to study drugs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients recruited from the clinical database of LAM patients across Australia and New Zealand. Allocation to intervention was concealed. Performed by central randomisation by phone /fax /computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Randomised double blind placebo controlled
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3350 0
Hospital
Name [1] 3350 0
LAM Fighting Fund, St.Vincents Hospital
Country [1] 3350 0
Australia
Funding source category [2] 3592 0
Charities/Societies/Foundations
Name [2] 3592 0
LAM Australia
Country [2] 3592 0
Australia
Primary sponsor type
Individual
Name
Dr.Deborah Yates
Address
Dept of Thoracic Medicine, Xavier 4 St.Vincents Hospital
390, Victoria Street, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 2995 0
Hospital
Name [1] 2995 0
St.Vincents Hospital
Address [1] 2995 0
390, Victoria Street,
Darlinghurst NSW 2010
Country [1] 2995 0
Australia
Other collaborator category [1] 277 0
Individual
Name [1] 277 0
A/Prof Allan R Glanville
Address [1] 277 0
Dept of Thoracic Medicine, Xavier 4
St.Vincents Hospital
390, Victoria Street, Darlinghurst NSW 2010
Country [1] 277 0
Australia
Other collaborator category [2] 278 0
Individual
Name [2] 278 0
Prof Judy Black
Address [2] 278 0
University of Sydney
NSW
Country [2] 278 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5374 0
St.Vincents Hospital HREC
Ethics committee address [1] 5374 0
390, Victoria Street,
Darlinghurst NSW 2010
Ethics committee country [1] 5374 0
Australia
Date submitted for ethics approval [1] 5374 0
Approval date [1] 5374 0
17/02/2007
Ethics approval number [1] 5374 0
H06/138

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28562 0
Address 28562 0
Country 28562 0
Phone 28562 0
Fax 28562 0
Email 28562 0
Contact person for public queries
Name 11719 0
Dr.Anu Krishnan
Address 11719 0
Dept of Thoracic Medicine, Xavier 4
St.Vincents Hospital
390, Victoria Street, Darlinghurst NSW 2010
Country 11719 0
Australia
Phone 11719 0
+61 2 83821111
Fax 11719 0
+61 2 83823084
Email 11719 0
akrishnan@stvincents.com.au
Contact person for scientific queries
Name 2647 0
Dr.Deborah Yates
Address 2647 0
Dept of Thoracic Medicine, Xavier 4
St.Vincents Hospital
390, Victoria Street, Darlinghurst NSW 2010
Country 2647 0
Australia
Phone 2647 0
+61 2 83821111
Fax 2647 0
+61 2 83823084
Email 2647 0
deborahy88@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.