Cystic FibrosisNCT02003079
Evaluating the Impact of Chronic Rhinosinusitis on the Health-Related Quality of Life Among Adults With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by St. Paul's Hospital, Canada at 1 site in Canada.
Trial summary
Individuals with Cystic Fibrosis (CF) have a defective protein, which is known as the cystic-fibrosis transmembrane regulator (CFTR). The CFTR transports salt and hydrates mucous. CFTR defects may result in the accumulation of thick mucous in the sinus cavities. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Cystic Fibrosis Questionnaire (Revised) for Teens/Adults
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 113 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Jun 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult individuals over the age of 19 years with a definitive diagnosis of Cystic Fibrosis.
Who may be able to join
- 19 years of age or older
- Definitive diagnosis of cystic fibrosis from positive genetic or sweat chloride test
- Currently enrolled at the St. Paul's Cystic Fibrosis Clinic
Who cannot join
- Individuals unable to understand the purpose, methods and conduct of this study.
- Patients unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Individuals with Cystic Fibrosis (CF) have a defective protein, which is known as the cystic-fibrosis transmembrane regulator (CFTR). The CFTR transports salt and hydrates mucous. CFTR defects may result in the accumulation of thick mucous in the sinus cavities. As a result, the tiny hair-like structures that sweep mucous out of the sinuses cannot function properly, which can lead to recurrent infection and swelling of the sinus walls. When symptoms are persistent for more than 12 weeks, this is known as chronic rhinosinusitis (CRS). The symptoms that are associated with CRS are nasal discharge, congestion, facial pain or pressure and reduced sense of smell. CRS in non-CF patients affects a large number of individuals in Canada and has been found to be associated with poor quality of life. In the CF population the life expectancy is increasing but chronic disease like CRS is becoming increasingly prevalent. Investigators currently do not know the impact that CRS has on the health-related quality of life in adults with CF and how many suffer from symptoms. The investigators aim to determine the impact of CRS among adults with CF, in order to gain a better understanding of chronic disease among these individuals. The investigators strongly feel this research will improve the referral processes between Respirologists and Otolaryngologists, thereby improving treatment and quality of life for patients.
- Conditions
- Cystic Fibrosis
- Being tested
- Cystic Fibrosis Questionnaire (Revised) for Teens/Adults
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cystic Fibrosis Questionnaire (Revised) for Teens/AdultsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed with or without Chronic Rhinosinusitis | Not described Receives: Behavioral: Cystic Fibrosis Questionnaire (Revised) for Teens/Adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Cystic Fibrosis-specific HRQoL score among those with and without CRS.
Subjects will complete questionnaires meant to assess the severity of their symptoms as a cumulative experience of the last two weeks leading up to the visit. Subjects will also undergo nasal endoscopy examination during the same visit. All of the study procedures and data collection will be completed in one visit.
Measured: One clinic visit (30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Javer, St. Paul's Hospital, Canada
- Investigators
- Amin R Javer, MD FRCSC FARS, Principal investigator, St Paul's Sinus Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003079
- Sponsor's protocol ID
- CFSinus-001
- Status last verified
- Nov 2014
- First submitted
- 11 Jul 2013
- Last updated
- 21 Nov 2014
- Results posted
- No
Publications
Habib AR, Buxton JA, Singer J, Wilcox PG, Javer AR, Quon BS. Association between Chronic Rhinosinusitis and Health-Related Quality of Life in Adults with Cystic Fibrosis. Ann Am Thorac Soc. 2015 Aug;12(8):1163-9. doi: 10.1513/AnnalsATS.201504-191OC.
PubMed 26011015
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Chronic Rhinosinusitis on the Health-Related Quality of Life Among Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02003079
- Acronym / sponsor ID
- CFSinus-001
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Dec 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.
Individuals with Cystic Fibrosis (CF) have a defective protein, which is known as the cystic-fibrosis transmembrane regulator (CFTR). The CFTR transports salt and hydrates mucous. CFTR defects may result in the accumulation of thick mucous in the sinus cavities. As a result, the tiny hair-like structures that sweep mucous out of the sinuses cannot function properly, which can lead to recurrent infection and swelling of the sinus walls. When symptoms are persistent for more than 12 weeks, this is known as chronic rhinosinusitis (CRS). The symptoms that are associated with CRS are nasal discharge, congestion, facial pain or pressure and reduced sense of smell. CRS in non-CF patients affects a large number of individuals in Canada and has been found to be associated with poor quality of life. In the CF population the life expectancy is increasing but chronic disease like CRS is becoming increasingly prevalent. Investigators currently do not know the impact that CRS has on the health-related quality of life in adults with CF and how many suffer from symptoms. The investigators aim to determine the impact of CRS among adults with CF, in order to gain a better understanding of chronic disease among these individuals. The investigators strongly feel this research will improve the referral processes between Respirologists and Otolaryngologists, thereby improving treatment and quality of life for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed with or without Chronic Rhinosinusitis | – | Behavioral: Cystic Fibrosis Questionnaire (Revised) for Teens/Adults |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult individuals over the age of 19 years with a definitive diagnosis of Cystic Fibrosis.
Key inclusion criteria (3 listed)
- 19 years of age or older
- Definitive diagnosis of cystic fibrosis from positive genetic or sweat chloride test
- Currently enrolled at the St. Paul's Cystic Fibrosis Clinic
Key exclusion criteria (2 listed)
- Individuals unable to understand the purpose, methods and conduct of this study.
- Patients unwilling to provide informed consent.
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 |
|---|---|---|
| Cystic Fibrosis Questionnaire (Revised) for Teens/Adults | Behavioural | Diagnosed with or without Chronic Rhinosinusitis |
Primary outcome
Difference in Cystic Fibrosis-specific HRQoL score among those with and without CRS.
Time frame: One clinic visit (30 minutes)
Subjects will complete questionnaires meant to assess the severity of their symptoms as a cumulative experience of the last two weeks leading up to the visit. Subjects will also undergo nasal endoscopy examination during the same visit. All of the study procedures and data collection will be completed in one visit.
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 21 Nov 2014.
- Derived from this study: PubMed 26011015Habib AR, Buxton JA, Singer J, Wilcox PG, Javer AR, Quon BS. Association between Chronic Rhinosinusitis and Health-Related Quality of Life in Adults with Cystic Fibrosis. Ann Am Thorac Soc. 2015 Aug;12(8):1163-9. doi: 10.1513/AnnalsATS.201504-191OC.
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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.
Amin R Javer, MD FRCSC FARS principal investigator
St Paul's Sinus Center
1 site 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, run by St. Paul's Hospital, Canada at 1 site in Canada.
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 3 inclusion and 2 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 21 Nov 2014. 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 Canada. 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?
Difference in Cystic Fibrosis-specific HRQoL score among those with and without CRS. (time frame: One clinic visit (30 minutes)). 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 NCT02003079, which also lists 1 linked publication.
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 21 Nov 2014.