CompletedNot Applicable

Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways

Canada28 participantsStarted 2008-04

Plain-language summary

The general objective is to elucidate the mechanisms whereby sex hormones may modulate the severity of respiratory disease. An important component of this proposal is a systematic and intensive approach to characterize how the cellular and cytokine components of airway inflammation respond to fluctuations in sex hormone levels. The effects of menstrual fluctuations in levels of sex hormones on inflammation and bacterial load in respiratory secretions of CF patients will also be determined.

Who can participate

Age range

14 Years – 28 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: FEMALES WITH CF * Sexually mature female CF patients followed at the Toronto CF Clinics of The Hospital for Sick Children (adolescents) or St. Michael's Hospital (adults) * 14-28 years of age * Diagnosis of CF is based on a typical clinical picture and confirmed by repeated sweat chloride values \> 60 mEq/L as determined by pilocarpine ionophoresis (minimum 100mg sweat) * Have regular, normal menses * Able to give consent on her own behalf FEMALES WITHOUT CF * Sexually mature females * 14-28 years of age * Have regular, normal menses * Able to give consent on her own behalf MALES WITH CF * Sexually mature male CF patients followed at the Toronto CF Clinics of The Hospital for Sick Children (adolescents) or St. Michael's Hospital (adults) * 14-28 years of age * Diagnosis of CF is based on a typical clinical picture and confirmed by repeated sweat chloride values \> 60 mEq/L as determined by pilocarpine ionophoresis (minimum 100mg sweat) * Able to give consent on his own behalf MALES WITHOUT CF * Sexually mature males * 14-28 years of age * Able to give consent on his own behalf Exclusion Criteria: * Is a smoker * Has had an upper respiratory tract infection within the preceding two weeks * Is taking systemic oral contraceptive therapy * Is pregnant * Has used furosemide or amiloride or had a pulmonary exacerbation in the previous month (Acute exacerbations are defined as 3 or more of the following symptoms or signs: increased cough, change in volu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Presence of inflammatory markers (cytokines, white blood cells), levels of LTF, STH and PIP. Serum levels of estrogen (E), progesterone (P), luteinizing hormone (LH) and follicle stimulating hormone (FSH) will be determined in female human subjects

Timeframe: For the female patients the visits will be timed so that one measure is taken in the luteal phase of their menstrual cycle and the other is taken during the follicular phase. Male patients will be asked to come to measure these levels two weeks apart.

Trial details

NCT IDNCT00700050

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-07-29

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