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

NCT00700050 | Completed

• 1 other identifier: 1000011620
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Sex hormones; Pseudomonas aeruginosa; Paediatrics

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

CF Females

CF females, 14 - 28 years old, sexually mature, with regular menstrual cycles, not on contraceptive Pill. No intervention is being tested - subjects studied with normal menstrual variations in serum hormone levels. Hypertonic saline may be used to induce sputum production by subjects who are otherwise unable to produce a satisfactory sputum sample.

Drug: Hypertonic saline

Non-CF Females

Non-CF control females, 14 - 28 years old, sexually mature, with regular menstrual cycles, not on contraceptive Pill. No intervention is being tested - subjects studied with normal menstrual variations in serum hormone levels. Hypertonic saline may be used to induce sputum production by subjects who are otherwise unable to produce a satisfactory sputum sample.

Drug: Hypertonic saline

CF Males

CF males, 14 - 28 years old. No intervention is being tested. Hypertonic saline may be used to induce sputum production by subjects who are otherwise unable to produce a satisfactory sputum sample.

Drug: Hypertonic saline

Non-CF males

Non-CF control males, 14 - 28 years old. No intervention is being tested. Hypertonic saline may be used to induce sputum production by subjects who are otherwise unable to produce a satisfactory sputum sample.

Drug: Hypertonic saline

Interventions

Hypertonic saline DRUG

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.

Also known as: Sodium chloride, inhalation;

CF Females

Eligibility Criteria

• Age: 14 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The primary study population are sexually mature cystic fibrosis (CF) females with regular natural menstrual cycles. For some measurements, they serve as their own controls. For other measurements, there are up to three control groups: non-CF females, CF males and non-CF males.

You may qualify if:

• 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)
• 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
• 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)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Unity Health Toronto: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum Blood

MeSH Terms

Conditions

Cystic Fibrosis; Pseudomonas Infections

Interventions

Saline Solution, Hypertonic; Sodium Chloride; Inhalation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Neil Sweezey, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Respirologist

Study Record Dates

• First Submitted: June 16, 2008
• First Posted: June 18, 2008
• Study Start: April 1, 2008
• Primary Completion: July 29, 2014
• Study Completion: July 29, 2014
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

CA (1)