Cystic FibrosisNCT00850551
Early Intervention in Pulmonary Exacerbation in Cystic Fibrosis
A study testing Early Intervention in people with Cystic Fibrosis, run by University of Washington at 1 site in United States.
Trial summary
This study will be performed at the University of Washington. Forty subjects with Cystic Fibrosis will be enrolled, with 20 randomized into the usual care arm and 20 randomized into the intervention arm. All subjects will be enrolled for 6 months and have 3 study visits. One at baseline, midpoint, and final. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Early Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years old
- Confirmed diagnosis of cystic fibrosis
- Chronically colonization wtih Pseudomonas defined by positive sputum or lower airway cultures on 2 or more occasions in any 12 month period
- Ability to participate in an interview and administration of questionnaire lasting 60 minutes
- Clinically stable without IV antibiotic treatment for a pulmonary exacerbation in the prior 2 weeks
- Ability to perform spirometry
- Have a home telephone line or home computer with internet connection
- Written informed consent
Who cannot join
- Colonization with burkholderia cepacia complex
- Confirmed diagnosis of allergic bronchopulmonary aspergillosis as defined by the CFF guidance document
- Currently receiving antimicrobial therapy to treat non-tuberculous mycobacterium
- History of prior solid organ transplant
- Inability to speak and read the English language well enough to complete questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
This study will be performed at the University of Washington. Forty subjects with Cystic Fibrosis will be enrolled, with 20 randomized into the usual care arm and 20 randomized into the intervention arm. All subjects will be enrolled for 6 months and have 3 study visits. One at baseline, midpoint, and final. The intervention arm subjects may have more study visits depending on their respiratory symptoms.
The intervention arm subjects will perform home spirometry twice a week with a PiKo-6 hand held spirometer. They will also have a home-based telemonitoring system connected to their phone line. They will be prompted twice a week to answer questions regarding their health via the telemonitor.
Read more
Subjects who are not able to utilize the home-based telemonitoring system will answer the questions regarding their health via the internet from their home computer.
If the subject's spirometry falls by greater than 10% from baseline or the CF respiratory symptoms change in 3 or more of the 8 respiratory symptoms captured by the telemonitor questionnaire, the subject will be called by the research staff and clinically evaluated by the study PIs within three days.
The usual care subjects will continue with their routine care at the University of Washington CF Clinic.
Read the detailed description
The study design is a single center, randomized non-blinded controlled clinical trial comparing usual care to a program of early identification and treatment of pulmonary exacerbation in adults with CF. Forty subjects will be enrolled a at the University of Washington with 20 subjects randomized into the usual care arm, and 20 randomized into the intervention arm.
Usual care is defined as the regular quarterly CF visits with acute visits triggered by calls from the patient to the clinic. Neither home assessment of spirometry or standardized home symptom assessment are a component of usual care. Treatment of a pulmonary exacerbation will be based on a standard protocol employing a standard definition and treatment regimen. This study will employ current standardized CF pulmonary exacerbation orders used at the University of Washington. Usual care arm subjects will have 3 study visits at baseline, midpoint, and final, over a period of 6 months.
The early intervention protocol will employ twice a week assessment of home spirometry and CF respiratory symptoms; we will employ a home based monitoring system from Philips called the Philips Remote Patient Monitoring system (TeleStation). The home monitoring system is connected to the patient's phone line; this system is currently used in clinical practice in the care of patients with diabetes and heart failure.
Subjects who do not have a home phone line will answer the CF respiratory questions via the internet from their home computer.
The home spirometry will be done using a PiKo-6 hand held spirometer up to 84 spirometry values. If the subject's spirometry falls by greater than 10% from baseline or the CF respiratory symptoms change in 3 or more of the 8 respiratory symptoms captured in the questionnaire, the subject will be called by the research staff and clinically evaluated by the study PIs within three days. This evaluation will include a history and physical exam along with repeat spirometry at the clinic. The intervention arm subjects will have 3 study visits at baseline, midpoint, and final, over a period of 6 months. They may have additional study visits depending on their respiratory symptoms or exacerbations during the 6 month study period.
- Conditions
- Cystic Fibrosis
- Being tested
- Early Intervention
- Keywords
- Early Intervention, Pulmonary Exacerbation, Cystic Fibrosis, Lung Function, Spirometry, Phillips Telemonitor, Home Spirometry, PiKo-6, Home Monitoring
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early InterventionOther
Also called Piko-6, Philips Telemonitor
Twice a week home spirometry and symptom assessment
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Usual Care Receives: Other: Early Intervention |
| Intervention | Other | Twice weekly home spirometry and symptom assessment Receives: Other: Early Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the feasibility of the use of home spirometry and home symptom assessment on the diagnosis of acute pulmonary exacerbation in adult patients with mild to moderate CF lung disease
Measured: 6 months
Secondary outcomes (1)
Assess the impact of the use of home spirometry, home symptom assessment and a protocolized approach to treatment of acute pulmonary exacerbation compared to usual care.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, Chris Goss, University of Washington
- Investigators
- Christopher H Goss, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850551
- Sponsor's protocol ID
- 35243-E/A
- Status last verified
- Nov 2016
- First submitted
- 23 Feb 2009
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no IPD
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention in Pulmonary Exacerbation in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00850551
- Acronym / sponsor ID
- 35243-E/A
- Conditions
- Cystic Fibrosis
- Keywords
- Early Intervention, Pulmonary Exacerbation, Cystic Fibrosis, Lung Function, Spirometry, Phillips Telemonitor, Home Spirometry, PiKo-6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Jan 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Feb 2009 (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.
This study will be performed at the University of Washington. Forty subjects with Cystic Fibrosis will be enrolled, with 20 randomized into the usual care arm and 20 randomized into the intervention arm. All subjects will be enrolled for 6 months and have 3 study visits. One at baseline, midpoint, and final. The intervention arm subjects may have more study visits depending on their respiratory symptoms.
The intervention arm subjects will perform home spirometry twice a week with a PiKo-6 hand held spirometer. They will also have a home-based telemonitoring system connected to their phone line. They will be prompted twice a week to answer questions regarding their health via the telemonitor.
Subjects who are not able to utilize the home-based telemonitoring system will answer the questions regarding their health via the internet from their home computer.
If the subject's spirometry falls by greater than 10% from baseline or the CF respiratory symptoms change in 3 or more of the 8 respiratory symptoms captured by the telemonitor questionnaire, the subject will be called by the research staff and clinically evaluated by the study PIs within three days.
The usual care subjects will continue with their routine care at the University of Washington CF Clinic.
Detailed description
The study design is a single center, randomized non-blinded controlled clinical trial comparing usual care to a program of early identification and treatment of pulmonary exacerbation in adults with CF. Forty subjects will be enrolled a at the University of Washington with 20 subjects randomized into the usual care arm, and 20 randomized into the intervention arm.
Usual care is defined as the regular quarterly CF visits with acute visits triggered by calls from the patient to the clinic. Neither home assessment of spirometry or standardized home symptom assessment are a component of usual care. Treatment of a pulmonary exacerbation will be based on a standard protocol employing a standard definition and treatment regimen. This study will employ current standardized CF pulmonary exacerbation orders used at the University of Washington. Usual care arm subjects will have 3 study visits at baseline, midpoint, and final, over a period of 6 months.
The early intervention protocol will employ twice a week assessment of home spirometry and CF respiratory symptoms; we will employ a home based monitoring system from Philips called the Philips Remote Patient Monitoring system (TeleStation). The home monitoring system is connected to the patient's phone line; this system is currently used in clinical practice in the care of patients with diabetes and heart failure.
Subjects who do not have a home phone line will answer the CF respiratory questions via the internet from their home computer.
The home spirometry will be done using a PiKo-6 hand held spirometer up to 84 spirometry values. If the subject's spirometry falls by greater than 10% from baseline or the CF respiratory symptoms change in 3 or more of the 8 respiratory symptoms captured in the questionnaire, the subject will be called by the research staff and clinically evaluated by the study PIs within three days. This evaluation will include a history and physical exam along with repeat spirometry at the clinic. The intervention arm subjects will have 3 study visits at baseline, midpoint, and final, over a period of 6 months. They may have additional study visits depending on their respiratory symptoms or exacerbations during the 6 month study period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Early InterventionUsual Care |
| Intervention | Other | Other: Early InterventionTwice weekly home spirometry and symptom assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female at least 18 years old
- Confirmed diagnosis of cystic fibrosis
- Chronically colonization wtih Pseudomonas defined by positive sputum or lower airway cultures on 2 or more occasions in any 12 month period
- Ability to participate in an interview and administration of questionnaire lasting 60 minutes
- Clinically stable without IV antibiotic treatment for a pulmonary exacerbation in the prior 2 weeks
Key exclusion criteria (5 listed)
- Colonization with burkholderia cepacia complex
- Confirmed diagnosis of allergic bronchopulmonary aspergillosis as defined by the CFF guidance document
- Currently receiving antimicrobial therapy to treat non-tuberculous mycobacterium
- History of prior solid organ transplant
- Inability to speak and read the English language well enough to complete questionnaire
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 |
|---|---|---|
| Early InterventionAlso: Piko-6, Philips TelemonitorTwice a week home spirometry and symptom assessment | Other | Intervention, Usual Care |
Primary outcome
Assess the feasibility of the use of home spirometry and home symptom assessment on the diagnosis of acute pulmonary exacerbation in adult patients with mild to moderate CF lung disease
Time frame: 6 months
1 secondary outcome
Assess the impact of the use of home spirometry, home symptom assessment and a protocolized approach to treatment of acute pulmonary exacerbation compared to usual care.
Time frame: 6 months
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 1 Dec 2016.
- Individual participant dataSharing planned: No. There is no IPD
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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 principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Intervention in people with Cystic Fibrosis, run by University of Washington 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 8 inclusion and 5 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 1 Dec 2016. 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.
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?
Assess the feasibility of the use of home spirometry and home symptom assessment on the diagnosis of acute pulmonary exacerbation in adult patients with mild to moderate CF lung disease (time frame: 6 months). 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 1 Dec 2016.