Cystic Fibrosis Clinical Trial
— Early CFOfficial title:
Viral Pathogenesis of Early Cystic Fibrosis Lung Disease
Verified date | April 2017 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | December 1, 2016 |
Est. primary completion date | December 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 4 Months |
Eligibility |
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. 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. |
Country | Name | City | State |
---|---|---|---|
Australia | The Royal Children's Hospital | Melbourne | Victoria |
Australia | Telethon Kids Institute | West Perth | |
United States | Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana |
United States | St. Louis Children's Hospital | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Indiana University School of Medicine | National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Bronchiectasis | To evaluate the association of early viruses on the development of early lung disease in CF infants as defined through comprehensive structural and airway modeling techniques. | 12 Months | |
Primary | Viral infection | To determine the effect(s) of viral infections on the evolution of endobronchial bacterial infection and inflammation in CF infants. | 12 months | |
Secondary | Pulmonary exacerbation rate | To identify the impact of respiratory viruses on the onset, frequency, and duration of respiratory symptoms in CF infants diagnosed through newborn screening. | 12 Months | |
Secondary | Forced Expiratory Volume | To assess development of early lung disease as defined through physiological measures of forced expiratory flows, lung volumes, and ventilation inhomogeneity in CF infants. | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04696198 -
Thoracic Mobility in Cystic Fibrosis Care
|
N/A | |
Completed |
NCT00803205 -
Study of Ataluren (PTC124™) in Cystic Fibrosis
|
Phase 3 | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03601637 -
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
|
Phase 3 | |
Terminated |
NCT02769637 -
Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
|
||
Recruiting |
NCT06012084 -
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
|
N/A | |
Recruiting |
NCT06032273 -
Lung Transplant READY CF 2: CARING CF Ancillary RCT
|
N/A | |
Recruiting |
NCT06030206 -
Lung Transplant READY CF 2: A Multi-site RCT
|
N/A | |
Recruiting |
NCT05392855 -
Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)
|
N/A | |
Recruiting |
NCT06088485 -
The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
|
||
Recruiting |
NCT04056702 -
Impact of Triple Combination CFTR Therapy on Sinus Disease.
|
||
Recruiting |
NCT04039087 -
Sildenafil Exercise: Role of PDE5 Inhibition
|
Phase 2/Phase 3 | |
Completed |
NCT04038710 -
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
|
||
Completed |
NCT04058548 -
Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
|
N/A | |
Completed |
NCT03637504 -
Feasibility of a Mobile Medication Plan Application in CF Patient Care
|
N/A | |
Recruiting |
NCT03506061 -
Trikafta in Cystic Fibrosis Patients
|
Phase 2 | |
Completed |
NCT03566550 -
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
|
||
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
Recruiting |
NCT04010253 -
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
|
N/A |