Cystic FibrosisCyFFNCT03843723
Cystic Fibrosis and Fit-to-Fly
An observational study of Cystic Fibrosis and Hypoxemia, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Due to the hypobaric hypoxia during air travel, some patients with Cystic Fibrosis (CF) need supplemental oxygen during air travel. The study aims to evaluate if adding exercise desaturation to the pre-flight evaluation will help predict requirements for in-flight supplemental oxygen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Hypoxemia, Lung Diseases
- What is being tested?
- Pre-flight evaluation
- How many people
- 79 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2019to 31 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with CF evaluated at the Norwegian Resource Centre for Cystic Fibrosis at the Dep. of Pulm. Med. Oslo University Hospital
Who may be able to join
- Adult CF patients (age from 18 years)
- Signed informed consent
Who cannot join
- Ongoing exacerbation
- Unable to fulfill a CPET or 6MWT
- Long-term oxygen treatment (LTOT)
- Severe heart disease
- Language problems that interfere with data collection
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital Ullevaal, Department of Pulmonary Medicine
Oslo, 0407
About this study
Official title: Exercise Pulse Oximetry and Pre-flight Evaluation of Adult Cystic Fibrosis (CF) Patients
Due to the hypobaric hypoxia during air travel, some patients with Cystic Fibrosis (CF) need supplemental oxygen during air travel.
The study aims to evaluate if adding exercise desaturation to the pre-flight evaluation will help predict requirements for in-flight supplemental oxygen.
Read the detailed description
According to the British Thoracic Society (BTS) recommendations regarding pre-flight evaluation in patients with pulmonary disease, pre-flight arterial oxygen saturation or lung function tests do not discriminate sufficiently between those who need supplemental oxygen during flights, and those who can do without.Therefore, more extensively use of Hypoxia Altitude Simulation test (HAST) has been advocated. However, this test is not widely available. Previous studies have shown that exercise testing is useful for the prediction of in-flight hypoxemia. The investigators have previously developed a pre-flight algorithm for patients with chronic obstructive pulmonary disease (COPD), based on oxygen saturation measured by pulse oximetry at rest and during exercise (six minute walking test (6MWT)). It remains unknown as to whether these results are applicable to the CF population.
The current study aims to validate the pre-flight algorithm for patients with CF. Since a maximum cardiopulmonary exercise test (CPET) is recommended in the routine CF-control, the investigators also aim to evaluate whether the use of CPET predicts in-flight hypoxemia with greater accuracy than 6MWT, and whether CPET may replace HAST.
- Conditions
- Cystic Fibrosis, Hypoxemia, Lung Diseases
- Being tested
- Pre-flight evaluation
- Keywords
- Pre-flight evaluation, Air travel, Pulseoximetry, Exercise desaturation, Hypobaria, Hypoxemia
- Medical subject headings
- Cystic Fibrosis, Hypoxia, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-flight evaluationOther
All the participants receive the interventions as part of their routine medical care during their annual visit for CF follow-up. Oxygen saturation are measured by pulse oximetry. Exercise testing is performed by 6MWT and CPET. Pre-flight evaluation is performed by HAST.
What is being measured
The primary outcome is the main question the study is designed to answer.
Does oxygen saturation during exercise predict in-flight hypoxemia in adult patients with CF?
Oxygen saturation is measured by pulse oximetry (SpO2) during exercise and HAST
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start1 Mar 2019
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Oslo University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Norwegian Resouce Centre for Cystic Fibrosis, Norwegian National Adivisory Unit on Rare Disorders, University Hospital, Akershus
- Responsible party
- Principal investigator, Aina Akerø, Oslo University Hospital
- Investigators
- Aina Akerø, MD PhD, Principal investigator, Oslo University Hospital, Dept. of Pulm. Med.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843723
- Sponsor's protocol ID
- 2018/1607 (REK)
- Acronym
- CyFF
- Status last verified
- Dec 2023
- First submitted
- 13 Feb 2019
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participants data available to other researchers due to restrictions from Oslo University Hospital
Publications
Edvardsen A, Akero A, Christensen CC, Ryg M, Skjonsberg OH. Air travel and chronic obstructive pulmonary disease: a new algorithm for pre-flight evaluation. Thorax. 2012 Nov;67(11):964-9. doi: 10.1136/thoraxjnl-2012-201855. Epub 2012 Jul 5.
PubMed 22767877Ahmedzai S, Balfour-Lynn IM, Bewick T, Buchdahl R, Coker RK, Cummin AR, Gradwell DP, Howard L, Innes JA, Johnson AO, Lim E, Lim WS, McKinlay KP, Partridge MR, Popplestone M, Pozniak A, Robson A, Shovlin CL, Shrikrishna D, Simonds A, Tait P, Thomas M; British Thoracic Society Standards of Care Committee. Managing passengers with stable respiratory disease planning air travel: British Thoracic Society recommendations. Thorax. 2011 Sep;66 Suppl 1:i1-30. doi: 10.1136/thoraxjnl-2011-200295. No abstract available.
PubMed 21856702Akero A, Edvardsen E, Finstad PL, Skrede B, Osterhaug M, Backman S, Edvardsen A, Skjonsberg OH. Air travel and cystic fibrosis: An algorithm to assess the risk of In-Flight Hypoxemia. J Cyst Fibros. 2025 Sep;24(5):963-969. doi: 10.1016/j.jcf.2025.05.004. Epub 2025 Jun 3.
PubMed 40467430
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Pulse Oximetry and Pre-flight Evaluation of Adult Cystic Fibrosis (CF) Patients
- ClinicalTrials.gov ID
- NCT03843723
- Acronym / sponsor ID
- CyFF / 2018/1607 (REK)
- Conditions
- Cystic Fibrosis, Hypoxemia, Lung Diseases
- Keywords
- Pre-flight evaluation, Air travel, Pulseoximetry, Exercise desaturation, Hypobaria, Hypoxemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Norwegian Resouce Centre for Cystic Fibrosis, Norwegian National Adivisory Unit on Rare Disorders, University Hospital, Akershus
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 18 Feb 2019 (actual)
- 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.
Due to the hypobaric hypoxia during air travel, some patients with Cystic Fibrosis (CF) need supplemental oxygen during air travel.
The study aims to evaluate if adding exercise desaturation to the pre-flight evaluation will help predict requirements for in-flight supplemental oxygen.
Detailed description
According to the British Thoracic Society (BTS) recommendations regarding pre-flight evaluation in patients with pulmonary disease, pre-flight arterial oxygen saturation or lung function tests do not discriminate sufficiently between those who need supplemental oxygen during flights, and those who can do without.Therefore, more extensively use of Hypoxia Altitude Simulation test (HAST) has been advocated. However, this test is not widely available. Previous studies have shown that exercise testing is useful for the prediction of in-flight hypoxemia. The investigators have previously developed a pre-flight algorithm for patients with chronic obstructive pulmonary disease (COPD), based on oxygen saturation measured by pulse oximetry at rest and during exercise (six minute walking test (6MWT)). It remains unknown as to whether these results are applicable to the CF population.
The current study aims to validate the pre-flight algorithm for patients with CF. Since a maximum cardiopulmonary exercise test (CPET) is recommended in the routine CF-control, the investigators also aim to evaluate whether the use of CPET predicts in-flight hypoxemia with greater accuracy than 6MWT, and whether CPET may replace HAST.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with CF evaluated at the Norwegian Resource Centre for Cystic Fibrosis at the Dep. of Pulm. Med. Oslo University Hospital
Key inclusion criteria (2 listed)
- Adult CF patients (age from 18 years)
- Signed informed consent
Key exclusion criteria (5 listed)
- Ongoing exacerbation
- Unable to fulfill a CPET or 6MWT
- Long-term oxygen treatment (LTOT)
- Severe heart disease
- Language problems that interfere with data collection
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 |
|---|---|---|
| Pre-flight evaluationAll the participants receive the interventions as part of their routine medical care during their annual visit for CF follow-up. Oxygen saturation are measured by pulse oximetry. Exercise testing is performed by 6MWT and CPET. Pre-flight evaluation is performed by HAST. | Other | – |
Primary outcome
Does oxygen saturation during exercise predict in-flight hypoxemia in adult patients with CF?
Time frame: 1 day
Oxygen saturation is measured by pulse oximetry (SpO2) during exercise and HAST
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 20 Dec 2023.
- Background: PubMed 22767877Edvardsen A, Akero A, Christensen CC, Ryg M, Skjonsberg OH. Air travel and chronic obstructive pulmonary disease: a new algorithm for pre-flight evaluation. Thorax. 2012 Nov;67(11):964-9. doi: 10.1136/thoraxjnl-2012-201855. Epub 2012 Jul 5.
- Background: PubMed 21856702Ahmedzai S, Balfour-Lynn IM, Bewick T, Buchdahl R, Coker RK, Cummin AR, Gradwell DP, Howard L, Innes JA, Johnson AO, Lim E, Lim WS, McKinlay KP, Partridge MR, Popplestone M, Pozniak A, Robson A, Shovlin CL, Shrikrishna D, Simonds A, Tait P, Thomas M; British Thoracic Society Standards of Care Committee. Managing passengers with stable respiratory disease planning air travel: British Thoracic Society recommendations. Thorax. 2011 Sep;66 Suppl 1:i1-30. doi: 10.1136/thoraxjnl-2011-200295. No abstract available.
- Derived from this study: PubMed 40467430Akero A, Edvardsen E, Finstad PL, Skrede B, Osterhaug M, Backman S, Edvardsen A, Skjonsberg OH. Air travel and cystic fibrosis: An algorithm to assess the risk of In-Flight Hypoxemia. J Cyst Fibros. 2025 Sep;24(5):963-969. doi: 10.1016/j.jcf.2025.05.004. Epub 2025 Jun 3.
- Individual participant dataSharing planned: No. There is no plan to make individual participants data available to other researchers due to restrictions from Oslo University Hospital
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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.
Aina Akerø, MD PhD principal investigator
Oslo University Hospital, Dept. of Pulm. Med.
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 and Hypoxemia, run by Oslo University Hospital at 1 site in Norway.
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 2 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 20 Dec 2023. 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 Norway. 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?
Does oxygen saturation during exercise predict in-flight hypoxemia in adult patients with CF? (time frame: 1 day). 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 NCT03843723, which also lists 3 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 20 Dec 2023.