|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
8 January 2018 |
|
Main ID: |
NCT03391414 |
|
Date of registration:
|
20/06/2012 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
|
|
Scientific title:
|
Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis |
|
Date of first enrolment:
|
August 2014 |
|
Target sample size:
|
12 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03391414 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Joseph M PIlewski, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Pittsburgh |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. FEV1 greater than 50% predicted.
2. Ability to spontaneously expectorate sputum (with or without chest physiotherapy).
3. Stable disease as defined by absence of exclusion criteria numbers 3-5 and clinician
assessment.
Exclusion Criteria:
1. Reactive airway disease
2. Use of inhaled hypertonic saline in the past 28 days
3. Use of IV antibiotics in the past 4 weeks
4. Changes in CF-related medications in the four weeks prior to study screening
5. SpO2 < 94% on room air or use of supplemental oxygen.
6. Presence of untreated gastroesophageal reflux disease (GERD) or residual acid reflux
symptoms in cases of treated GERD more than three times per week.
7. Pregnant or nursing females.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cystic Fibrosis
|
|
Intervention(s)
|
|
Drug: hypertonic bicarbonate
|
|
Drug: sodium chloride
|
|
Primary Outcome(s)
|
|
Exhaled breath condensate pH change
[Time Frame: two time points (baseline and four (4) hours)]
|
|
Secondary Outcome(s)
|
|
Expectorated sputum change
[Time Frame: two time points (Baseline and four (4) hours)]
|
|
Spirometry
[Time Frame: two time points (baseline and four (4) hours)]
|
|
Secondary ID(s)
|
|
PRO09120363
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|