Gastroesophageal RefluxPhase 1NCT01841307
Cromolyn Detection of Silent Aspiration
A Phase 1 study testing Cromolyn Sodium in people with Gastroesophageal Reflux and Respiratory Aspiration, run by University of California, San Francisco at 1 site in United States.
Trial summary
The overall purpose of this project is to develop and validate a simple, non-invasive method to detect aspiration of gastro-intestinal fluid into the respiratory tract. In the inpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 4 ingestions (at 2h… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux, Respiratory Aspiration, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Cromolyn Sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Sep 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants
- Adult non-smokers
- Females only - negative urine pregnancy test
- Lung transplant patients
- Adult patients awaiting (or recently undergone) - lung transplant
- Evidence of gastro-esophageal reflux with probable recurrent aspiration
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- Females only - negative urine pregnancy test
- Idiopathic pulmonary fibrosis patients
- Adult patients currently enrolled in on-going University of California, San Francisco study of prevalence of recurrent GER with aspiration in idiopathic pulmonary fibrosis
- Evidence of gastro-esophageal reflux with probable recurrent aspiration
- Females only - negative urine pregnancy test
Who cannot join
- Healthy participants
- History of dysphagia
- GER
- Recurrent cough
- Asthma
- Pneumonia after childhood
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- Sleep impairment
- Use of drugs or alcohol impairing consciousness
- Impaired gag reflex on physical examination
- Any other significant medical illness (e.g., morbid obesity, diabetes, neurologic disease, etc.) that in the opinion of the investigator could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study
- Greater than 5 pack years lifetime smoking history
- History of intolerance or allergy to cromolyn sodium
- Lung transplant patients
- History of intolerance or allergy to cromolyn sodium
- History of Nissen fundoplication
- IPF patients
- History of intolerance or allergy to cromolyn sodium
- History of Nissen fundoplication
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Airway Clinical Research Center
San Francisco, California, 94143
About this study
Official title: Development and Validation of Test for Gastro-esophageal Reflux and Aspiration
The overall purpose of this project is to develop and validate a simple, non-invasive method to detect aspiration of gastro-intestinal fluid into the respiratory tract. In the inpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 5 healthy control subjects and 5 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration. In the outpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 1 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 10 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration.
- Conditions
- Gastroesophageal Reflux, Respiratory Aspiration, Idiopathic Pulmonary Fibrosis, Lung Transplantation
- Being tested
- Cromolyn Sodium
- Medical subject headings
- Gastroesophageal Reflux, Respiratory Aspiration, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cromolyn SodiumDrug
Also called Gastrocrom
| Study group | Role | What they receive |
|---|---|---|
| Gastrocrom | Experimental | 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium (inpatient) OR 2 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium (outpatient) Receives: Drug: Cromolyn Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cromolyn in urine collected overnight
Measured: Collected overnight (6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startJul 2015
- Primary completionMar 2017
- Study completionSep 2017
Why it stopped: Difficulty recruiting; Funding ended; interim analysis provided sufficient data for interpretation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Aradign Corportation, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Homer Boushey, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841307
- Sponsor's protocol ID
- 13-11080
- Status last verified
- Feb 2019
- First submitted
- 23 Apr 2013
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Test for Gastro-esophageal Reflux and Aspiration
- ClinicalTrials.gov ID
- NCT01841307
- Acronym / sponsor ID
- 13-11080
- Conditions
- Gastroesophageal Reflux, Respiratory Aspiration, Idiopathic Pulmonary Fibrosis, Lung Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting; Funding ended; interim analysis provided sufficient data for interpretation.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Aradign Corportation, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of this project is to develop and validate a simple, non-invasive method to detect aspiration of gastro-intestinal fluid into the respiratory tract. In the inpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 5 healthy control subjects and 5 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration. In the outpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 1 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 10 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastrocrom | Experimental | Drug: Cromolyn Sodium4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium (inpatient) OR 2 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium (outpatient) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy participants
- Adult non-smokers
- Females only - negative urine pregnancy test
- Lung transplant patients
- Adult patients awaiting (or recently undergone) - lung transplant
Key exclusion criteria (18 listed)
- Healthy participants
- History of dysphagia
- GER
- Recurrent cough
- Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cromolyn SodiumAlso: Gastrocrom | Drug | Gastrocrom |
Primary outcome
Total cromolyn in urine collected overnight
Time frame: Collected overnight (6 hours)
Results and safety
The study was stopped early (reason given: Difficulty recruiting; Funding ended; interim analysis provided sufficient data for interpretation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Homer Boushey, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cromolyn Sodium in people with Gastroesophageal Reflux and Respiratory Aspiration, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty recruiting; Funding ended; interim analysis provided sufficient data for interpretation.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cromolyn in urine collected overnight (time frame: Collected overnight (6 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.