Cystic FibrosisSTOP-OB-13NCT02109822
Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerb. in Patients With CF
An observational study of Cystic Fibrosis and Lung Infection, run by University of Washington at 12 sites in United States.
Trial summary
The goal of this research study is to better understand current treatment practices for pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient Registry (CFFNPR)can be used for this type of study. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis, Lung Infection, Cystic Fibrosis Pulmonary Exacerbation
- Type of treatment
- Injection or infusion
- How many people
- 220 participants
- Where
- 12 sitesUnited States
- Study dates
- Jan 2014to Jun 2015
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Cystic Fibrosis who are hospitalized with a pulmonary exacerbation treated with intravenous antibiotics.
Who may be able to join
- Male or female ≥12 years of age at Visit 1
- Enrolled in the CFFNPR (Patients may enroll in the Registry at Visit 1 if not previously enrolled.)
- Current hospitalization for treatment of a pulmonary exacerbation
- Planned hospital admission of at least 5 days with intravenous (IV) antibiotics at Visit 1
- Able to perform spirometry at admission and willing to perform spirometry on subsequent treatment and visit days
- Willing and able to complete symptom score daily
- Willing to return for a follow up visit at end of treatment (if necessary) and 28 days after start of IV antibiotic therapy
- Written informed consent (and assent when applicable) obtained from the participant or participant's legal representative
Who cannot join
- Previous enrollment in this study
- Treatment with IV antibiotics in the 6 weeks prior to Visit 1
- Admission to the intensive care unit for current pulmonary exacerbation
- Pneumothorax on admission
- Current hospitalization for scheduled pulmonary clean out
- Current hospitalization for sinusitis as the primary diagnosis
Show all 10Show fewer
- Massive hemoptysis defined as > 250 cc in a 24 hour period, or 100 cc/day over 4 consecutive days occurring within one week of Visit 1
- Current pulmonary exacerbation thought to be due to allergic bronchopulmonary aspergillosis (ABPA)
- Ongoing treatment with prednisone equivalent >10 mg/day for greater than 2 weeks initiated prior to Visit 1
- History of solid organ transplantation Currently receiving antimicrobial therapy to treat non-tuberculous mycobacterium (e.g., M. abscessus, M. avium complex)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Johns Hopkins
Baltimore, Maryland, 21205
CFF Adult Program University of Alabama
Birmingham, Alabama, 35233
Medical University of South Carolina
Charleston, South Carolina, 29425
CFF Care Center & Pediatric Program Rainbow Babies and Children's Hospita
Cleveland, Ohio, 44106
Rainbow Babies and Children's Hospital & University Hospitals Case Medical Center
Cleveland, Ohio, 44106
CFF Care Center & Pediatric Program The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
National Jewish Health
Denver, Colorado, 80206
CFF Care Center & Pediatric Program University of Wisconsin
Madison, Wisconsin, 53706
CFF Care Center & Pediatric Program Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
CFF Care Center & Pediatric Program Seattle Children's Hospital
Seattle, Washington, 98105
University of Washington
Seattle, Washington, 98195
CFF Care Center Arizona Health Science Center
Tucson, Arizona, 85721
About this study
Official title: Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
The goal of this research study is to better understand current treatment practices for pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient Registry (CFFNPR)can be used for this type of study.
Read the detailed description
Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during which symptoms of lung infection increase and lung function decreases. These pulmonary exacerbations (PEs) are treated with varying antibiotics for varying time periods based on needs determined by individual patients, their families, and the health care providers. Cystic fibrosis pulmonary guidelines for the treatment of PE published by the Cystic Fibrosis Foundation (CFF) in 2009 provided recommendations for treatment and also identified key questions for which additional studies were needed.
Standard treatment for PE involves many facets including selection of antibiotics, duration of use, and outcomes that define treatment success. Understanding current treatment practices and measures of treatment success are needed before a study can be designed to define optimal treatment strategies.
This is a multi-center, prospective, observational study designed to prospectively follow patients with CF that are initially admitted to the hospital for treatment of a pulmonary exacerbation.
- Keywords
- Cystic Fibrosis, Pulmonary Exacerbation, Lung Infection, Cystic Fibrosis Foundation, Cystic Fibrosis Foundation National Patient Registry
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CF patients with pulmonary exacerbations | Patients with CF who are hospitalized with a pulmonary exacerbation treated with intravenous antibiotics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using the CFF National Patient Registry
Assess feasibility using the CFF National Patient Registry as measured by the accuracy of data entry
Measured: 28 days from time of start of IV antibiotic therapy.
Secondary outcomes (1)
Physician and patient level clinical outcomes for their use in comparative studies of CF pulmonary exacerbations to determine the optimal treatment endpoints
Evaluate physician assessment of treatment response as measured by the physician treatment assessment questionnaire. Evaluate change in lung function and patient reported respiratory symptoms and quality of life in response to treatment of an acute pulmonary exacerbation.
Measured: During hospitalization and during a period following discharge of 28 days from time of start of IV antibiotic therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, Chris Goss, University of Washington
- Investigators
- Christopher H. Goss, MD MSc, Principal investigator, University of WashingtonPatrick Flume, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109822
- Sponsor's protocol ID
- 46256-EA
- Acronym
- STOP-OB-13
- Status last verified
- Oct 2016
- First submitted
- 6 Mar 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be available once the primary manuscripts are published. Data without identifiers will be available through the Cystic Fibrosis Therapeutics Development Network Coordinating Center once an application to use the data is approved.
Publications
VanDevanter DR, Heltshe SL, Sanders DB, West NE, Skalland M, Flume PA, Goss CH; STOP-OB Study. Changes in symptom scores as a potential clinical endpoint for studies of cystic fibrosis pulmonary exacerbation treatment. J Cyst Fibros. 2021 Jan;20(1):36-38. doi: 10.1016/j.jcf.2020.08.006. Epub 2020 Aug 13.
PubMed 32800708Stuart Elborn J, Geller DE, Conrad D, Aaron SD, Smyth AR, Fischer R, Kerem E, Bell SC, Loutit JS, Dudley MN, Morgan EE, VanDevanter DR, Flume PA. A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients. J Cyst Fibros. 2015 Jul;14(4):507-14. doi: 10.1016/j.jcf.2014.12.013. Epub 2015 Jan 13.
PubMed 25592656
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02109822
- Acronym / sponsor ID
- STOP-OB-13 / 46256-EA
- Keywords
- Cystic Fibrosis, Pulmonary Exacerbation, Lung Infection, Cystic Fibrosis Foundation, Cystic Fibrosis Foundation National Patient Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, Cystic Fibrosis Foundation
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Apr 2014 (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 goal of this research study is to better understand current treatment practices for pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient Registry (CFFNPR)can be used for this type of study.
Detailed description
Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during which symptoms of lung infection increase and lung function decreases. These pulmonary exacerbations (PEs) are treated with varying antibiotics for varying time periods based on needs determined by individual patients, their families, and the health care providers. Cystic fibrosis pulmonary guidelines for the treatment of PE published by the Cystic Fibrosis Foundation (CFF) in 2009 provided recommendations for treatment and also identified key questions for which additional studies were needed.
Standard treatment for PE involves many facets including selection of antibiotics, duration of use, and outcomes that define treatment success. Understanding current treatment practices and measures of treatment success are needed before a study can be designed to define optimal treatment strategies.
This is a multi-center, prospective, observational study designed to prospectively follow patients with CF that are initially admitted to the hospital for treatment of a pulmonary exacerbation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF patients with pulmonary exacerbations | – | –Patients with CF who are hospitalized with a pulmonary exacerbation treated with intravenous antibiotics. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Cystic Fibrosis who are hospitalized with a pulmonary exacerbation treated with intravenous antibiotics.
Key inclusion criteria (8 listed)
- Male or female ≥12 years of age at Visit 1
- Enrolled in the CFFNPR (Patients may enroll in the Registry at Visit 1 if not previously enrolled.)
- Current hospitalization for treatment of a pulmonary exacerbation
- Planned hospital admission of at least 5 days with intravenous (IV) antibiotics at Visit 1
- Able to perform spirometry at admission and willing to perform spirometry on subsequent treatment and visit days
Key exclusion criteria (10 listed)
- Previous enrollment in this study
- Treatment with IV antibiotics in the 6 weeks prior to Visit 1
- Admission to the intensive care unit for current pulmonary exacerbation
- Pneumothorax on admission
- Current hospitalization for scheduled pulmonary clean out
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of using the CFF National Patient Registry
Time frame: 28 days from time of start of IV antibiotic therapy.
Assess feasibility using the CFF National Patient Registry as measured by the accuracy of data entry
1 secondary outcome
Physician and patient level clinical outcomes for their use in comparative studies of CF pulmonary exacerbations to determine the optimal treatment endpoints
Time frame: During hospitalization and during a period following discharge of 28 days from time of start of IV antibiotic therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 32800708VanDevanter DR, Heltshe SL, Sanders DB, West NE, Skalland M, Flume PA, Goss CH; STOP-OB Study. Changes in symptom scores as a potential clinical endpoint for studies of cystic fibrosis pulmonary exacerbation treatment. J Cyst Fibros. 2021 Jan;20(1):36-38. doi: 10.1016/j.jcf.2020.08.006. Epub 2020 Aug 13.
- Derived from this study: PubMed 25592656Stuart Elborn J, Geller DE, Conrad D, Aaron SD, Smyth AR, Fischer R, Kerem E, Bell SC, Loutit JS, Dudley MN, Morgan EE, VanDevanter DR, Flume PA. A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients. J Cyst Fibros. 2015 Jul;14(4):507-14. doi: 10.1016/j.jcf.2014.12.013. Epub 2015 Jan 13.
- Individual participant dataSharing planned: Yes. Data will be available once the primary manuscripts are published. Data without identifiers will be available through the Cystic Fibrosis Therapeutics Development Network Coordinating Center once an application to use the data is approved.
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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.
Christopher H. Goss, MD MSc principal investigator
University of Washington
Patrick Flume, MD principal investigator
Medical University of South Carolina
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Lung Infection, run by University of Washington at 12 sites 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of using the CFF National Patient Registry (time frame: 28 days from time of start of IV antibiotic therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02109822, which also lists 2 linked publications.
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 26 Oct 2016.