Clinical trial

Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways - A Pilot Study

Name

1000011620

Description

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.

Trial arms

Trial start

2008-04-01

Estimated PCD

2014-07-29

Trial end

2014-07-29

Status

Completed

Treatment

Hypertonic saline

Subjects will be asked to expectorate sputum samples. If necessary to achieve this, subjects will inhale wet-nebulized 3% saline for up to 7 minutes each for up to 3 cycles.

Arms:

CF Females

Other names:

Sodium chloride, inhalation;

Hypertonic saline

Subjects will be asked to expectorate sputum samples. If necessary to achieve this, subjects will inhale wet-nebulized 3% saline for up to 7 minutes each for up to 3 cycles.

Arms:

Non-CF Females

Other names:

Sodium chloride, inhalation

Hypertonic saline

Subjects will be asked to expectorate sputum samples. If necessary to achieve this, subjects will inhale wet-nebulized 3% saline for up to 7 minutes each for up to 3 cycles.

Arms:

CF Males

Other names:

Sodium chloride, inhalation

Hypertonic saline

Subjects will be asked to expectorate sputum samples. If necessary to achieve this, subjects will inhale wet-nebulized 3% saline for up to 7 minutes each for up to 3 cycles.

Arms:

Non-CF males

Other names:

Sodium chloride, inhalation

Size

Primary endpoint

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

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.

Eligibility criteria

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 volume, colour or thickness of the sputum, fever, hemoptysis, increased shortness of breath, change in their chest radiograph or a fall in pulmonary function (FEV1) of \>10% from baseline) * Unable to give consent on his/her own behalf

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'CROSS_SECTIONAL'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Sputum Blood'}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}

Updated at

2024-06-28

1 organization

1 product

1 indication

Organization

The Hospital for Sick Children

Product

Hypertonic saline

Indication

Cystic Fibrosis