Status:
COMPLETED
Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Unity Health Toronto
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
14-28 years
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 approa...
Detailed Description
Most CF patients die because of chronic lung infection with P. aeruginosa, chronic inflammation and progressive airway damage. Agents that reduce inflammation or enhance airway antibacterial defences ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 29 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00700050
Start Date
April 1 2008
End Date
July 29 2014
Last Update
June 28 2024
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada