Status:
COMPLETED
Inflammatory and Microbiologic Markers in Sputum: Comparing Cystic Fibrosis With Primary Ciliary Dyskinesia
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Cystic Fibrosis
Primary Ciliary Dyskinesia
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
The objective of this study is to compare the lower airways inflammatory response to infection/pulmonary exacerbation among children known to have Primary Ciliary Dyskinesia (PCD) with children known ...
Detailed Description
The inflammatory response to infection and pulmonary exacerbation in CF is well documented, as is the response to intravenous antibiotic treatment. On the other hand, the inflammatory response to infe...
Eligibility Criteria
Inclusion
- Diagnosis of Cystic Fibrosis (CF) as defined by two or more clinical features of CF and a documented sweat chloride \> 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease-causing mutations or a diagnosis of Primary Ciliary Dyskinesia (PCD) as follows: definite PCD (compatible phenotype, diagnostic abnormality of ciliary ultrastructure and/or two disease-causing gene mutations) or "probable" PCD (compatible phenotype, ciliary biopsy not diagnostic but low nasal NO (\<100nl/min) with negative investigation screen for both CF and immunodeficiency
- Informed consent and verbal assent (as appropriate) provided by the subject's parent or legal guardian and the subject
- 6-18 years of age at enrolment and able to perform reproducible spirometry
- Clinically stable at enrolment (FEV \> 30%, oxyhaemoglobin sats \> 93%)
- Ability to comply with study visits and study procedures
Exclusion
- Respiratory culture positive for non-tuberculous mycobacteria (NTM), Stenotrophomonas maltophilia, Aspergillus fumigatus, Burkholderia cepacia complex, or Pseudomonas aeruginosa within past year.
- Use of intravenous antibiotics or oral quinolones within previous 14 days
- Use of inhaled antibiotics within the previous 28 days
- Pneumothorax or haemoptysis
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01155115
Start Date
January 1 2010
End Date
December 1 2014
Last Update
May 22 2015
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8