Hormonal Influences on the Airways

Study ID
STU 062011-095

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Ashley Keller
214-648-2817
ashley.keller@utsouthwestern.edu

Principal Investigator
Raksha Jain

Summary

This study will include cystic fibrosis patients followed at uTSW or Children's Medical Center who are greater or equal to 16 years of age. a total of 20 subjects may be consented at uTSW or Children's Medical Center.

We will follow CF women prospectively to assess lung indices during various ovulatory phases, and on and off hormone modulating treatment.

The core study will follow 1 month of natural ovulatory cycles with a visit in each of the three main phases (menses, follicular, luteal phase). Subsequently, subjects may opt to participate in the sub-study. in the sub-study, following their menses, women will be given Leuprorelin intramuscular injection (Lupron 11.25 mg iM), which lasts 3 months to inhibit Luteinizing hormone (LH) and Follicle Stimulating Hormone (FSH) secretion and ultimately other sex hormones. While hormones are suppressed, subjects will be given oral estrogen (estrace 2 mg BiD) for 2 weeks, estrogen with progesterone (estrace 2 mg BiD and Prometrium 200 mg BiD) for 2 weeks, and progesterone (Prometrium 200 mg BiD) alone for 2 weeks. if subjects participate in the sub-study they will undergo 8 visits over approximately 90 days and serve as their own controls. at each visit, spirometry, Respiratory and Systemic Symptoms Questionnaire (RSSQ), vitals, a nasal mucocilliary clearance (saccharin) test, and blood and sputum specimens will be collected.

Subjects will be required to stop any hormone contraceptive or oral or inhaled steroid 1 month prior to start of the study. urine pregnancy tests will be performed at screening and at every visit. all women will receive a urine pregnancy test before beginning the study and at visits 4, 5, 6, 7, and 8.

The estimated time for completion of this project is 4 years. it will take 2-3 years to identify, consent subjects, and to collect pertinent data. it will take one more year to analyze the data and write appropriate manuscripts.

Participant Eligibility


* Female CF patients followed at Children[Single Quote]s Medical Center and U.T. Southwestern.

* Must be greater than or equal to 16 years of age.

* All subjects must understand and sign the informed consent.

* Subjects 16 or 17 years old must have at least one parent sign consent and give assent.

* Subjects must have the ability to read and write in English.

* Confirmation of CF by sweat test or genetic test.

* Stable health status (lack of exacerbation in the prior 2 months).

* History of regular menstrual cycles (26-34 days) for the previous 2 months.