Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT01059318
Eligibility Criteria:
Inclusion Criteria:
* Female aged \>/= 18 years with a diagnosis of LAM
* Pulmonary function abnormalities as follows:
* FEV1 of ≤ 80% of the predicted value following administration of a standard dose of a short acting β2-agonist (\*200 µg Salbutamol, measured between 10 and 15 minutes of inhalation) OR
* FEV1 \< 90% of the predicted value of bronchodilator following administration of a standard dose of a short acting β2-agonist (\*200 µg Salbutamol, measured between 10 and 15 minutes of inhalation) and DLco (uncorrected) \<80% predicted.
* Female patients including those of childbearing potential will be included in this study.
* Negative pregnancy test at screening and baseline
Exclusion Criteria:
* FEV1\<50% of predicted post-bronchodilator.
* Change in FVC (ml) \> ± 15% of screening value at baseline visit (not less than 14d after screening visit).
* Use of any medicine containing estrogen in the 4 months prior to the screening visit and for the duration of the study
* Significant hematologic, renal, hepatic laboratory abnormality or amylase \> 1.5x the upper limit of the normal range at the screening or baseline visits
* Fasting blood glucose \> 126mg/dl or random blood glucose \>200mg/dl at screening and/or baseline
* Recent surgery (involving entry into a body cavity or requiring sutures) within 2 months of the screening visit or any evidence of unhealed surgical wound.
* Uncontrolled hyperlipidemia (defined as persistent elevation of total cholesterol or triglycerides \>6.5nM/L) or a history of clinical atherosclerotic disease including heart attack, angina, peripheral vascular disease or stroke.
* Previous organ transplantation
* Inability to give informed consent
* Inability to perform pulmonary function or 6 minute walk tests and imaging assessments
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01059318
Study Brief:
Protocol Section:
NCT01059318