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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01973192




Registration number
NCT01973192
Ethics application status
Date submitted
17/09/2013
Date registered
31/10/2013
Date last updated
4/04/2017

Titles & IDs
Public title
Viral Pathogenesis of Early Cystic Fibrosis Lung Disease
Scientific title
Viral Pathogenesis of Early Cystic Fibrosis Lung Disease
Secondary ID [1] 0 0
1R01HL116211-01
Secondary ID [2] 0 0
1R01HL116211-01
Universal Trial Number (UTN)
Trial acronym
Early CF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Viral infection
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Pulmonary exacerbation rate
Timepoint [1] 0 0
12 Months
Secondary outcome [2] 0 0
Forced Expiratory Volume
Timepoint [2] 0 0
12 months

Eligibility
Key inclusion criteria
1. Diagnosis of CF by newborn screening, at least one clinical feature of CF, and
documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine
iontophoresis or compatible genotype with two identifiable mutant CFTR alleles.

2. Less than 4 months of age at Screening Visit

3. Ability to comply with study visits and study procedures as judged by site
investigator.
Minimum age
2 Months
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Intercurrent respiratory illness, defined as increase in cough, wheezing, or
respiratory rate with onset 14 days before iPFT-bronchoscopy visit.

2. Measured hemoglobin oxygen saturation less than 95% during the iPFT-bronchoscopy
visit.

3. History of adverse reaction to sedation.

4. Clinically significant upper airway obstruction as determined by the site
investigator.

5. Severe gastroesophageal reflux, defined as persistent frequent emesis despite therapy.

6. Major organ dysfunction, not including pancreatic dysfunction.

7. Physical findings that would compromise the safety of the subject or the quality of
the study data as determined by site investigator.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Children's Hospital - Melbourne
Recruitment hospital [2] 0 0
Telethon Kids Institute - West Perth
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
6872 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Indiana
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri

Funding & Sponsors
Primary sponsor type
Other
Name
Indiana University School of Medicine
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institutes of Health (NIH)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to test the hypothesis that early viral infections alter the
bacterial flora and inflammatory profile in the airway and accelerate progression of
pulmonary disease in infants with cystic fibrosis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01973192
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephanie D. Davis, MD
Address 0 0
Indiana University School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01973192