AsthmaNCT04142905
Is Asthma in Subjects With Obstructive Sleep Apnoea (OSA) Due to Dysanapsis
An observational study of Asthma and Obstructive Sleep Apnoea (OSA), run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Intention to review patient letters from sleep clinic to see if their lung function fit in with Dysynapsis in wheezing patients or if it is true asthma Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asthma, Obstructive Sleep Apnoea (OSA), Dysanapis
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Feb 2021to 8 Apr 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients attending the Obstructive Sleep Apnea Clinic at Norfolk \& Norwich University Hospital NHS Foundation Trust
Who may be able to join
- Any subject in Obstructive Sleep Apnea clinic.
Who cannot join
- Only exclusion criteria is if they have no recorded lung function in their notes
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY
About this study
Intention to review patient letters from sleep clinic to see if their lung function fit in with Dysynapsis in wheezing patients or if it is true asthma
Read the detailed description
There is no evidence that the World Wide prevalence of asthma is declining. There is some evidence that this Western disease may give the appearance of declining prevalence due to improved healthcare. However evidence from the Office of National Statistics suggests that the mortality rate for asthma may be increasing year on since 2007 until 2017. The true burden of asthma in the United Kingdom is difficult to ascertain.
Obesity has effects on lung function which lead to low functional residual capacity and low end reserve volume. This leads to rapid shallow breaths near to the airway closing pressure and lung closing volume as illustrated in this review. This suggests that obesity itself may be a source of breathlessness.
High Body Mass Index (BMI) has been shown to be associated with asthma. It was also associated with wheeze that is not asthma. This finding suggests that obesity in itself may be linked to wheeze which is not asthma. It has been shown in children that sleep disordered breathing is associated with asthma as well as wheeze. Obese children are known to display dysanapsis (airway cross sectional area is small for the size of the lung) whether associated with or without asthma, however if associated with asthma, the severity of asthma can be worse.
AIM: To investigate if asthma is truly associated with Sleep disordered breathing in adult subjects. To investigate if there is an association of wheeze with dysanapsis in patients with sleep disordered breathing
NULL HYPOTHESIS: There is no difference between subjects who have sleep disordered breathing with asthma and those subjects who have sleep disordered breathing without asthma, with respect to lung function parameters.
Methods
Initially the investigators' aim is to interrogate clinical records and look at lung function testing in subjects with and without asthma who attend the sleep disordered breathing clinic. The investigators intend to investigate 100 with asthma in the sleep clinic and 100 without asthma in the sleep clinic. The Investigators will also look at eosinophil results of those with asthma compared to those without asthma and any markers of atopy.
The investigators will use Statistical Package for the Social Sciences (SPSS) to undertake simple frequency analysis and cross tabs as well as odds ratio from binary logistic regression.
References - Refer to References Section
Appendix 1
Data Collection Sheet for those with confirmed diagnosis of Obstructive sleep apnoea
Name and Date of Birth and details
Age
Weight ______Height___________Body Mass Index _________Gender at birth ___Male____Female___ Asthma diagnosis made by General Practitioner or Respiratory physician or no diagnosis of asthma (circle correct)
DATE of Test ___/___/___FEV1_______FEV1%_______
FVC_________FVC%__________
DATE of Test ___/___/___FEV1_______FEV1%_______
FVC_________FVC%__________
Dysanapsis FEV1/FVC <0.8 Yes/No FEV1/FVC <0.7 Yes/No (circle correct)
AHI/hr 5-15 16-29 >30 (circle correct)
Eosinophil count MAX in past 12 months________x109/L MAX ever ______ x109/L
DATE________
RAST test positive for which antigens
Smoking history start age________________ Pack years________________
- Conditions
- Asthma, Obstructive Sleep Apnoea (OSA), Dysanapis
- Medical subject headings
- Asthma, Sleep Apnea, Obstructive
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 |
|---|---|---|
| Patients With Asthma | Subjects with sleep disordered breathing with asthma | |
| Patients Without Asthma | Subjects with sleep disordered breathing without asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defined dysynapsis in patients with asthma and obstructive sleep apnoea (OSA)
The investigator will refer to the Sleep Disordered Breathing Clinic records to investigate the prevalence of dysanapsis in patients with Sleep disordered breathing, in patients with asthma compared to those without asthma.
Measured: 6 years
Secondary outcomes (2)
Apnea-Hypopnea Index (AHI)
The investigator will refer to the Sleep Disordered Breathing Clinic records to compare measures of Apnea-Hypopnea Index (AHI) in patients with and without asthma.
Measured: 6 years
Eosinophil count
The investigator will refer to the Sleep Disordered Breathing Clinic records to compare Eosinophil count in patients with and without asthma.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start10 Feb 2021
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142905
- Sponsor's protocol ID
- 269072
- Status last verified
- Jun 2026
- First submitted
- 25 Oct 2019
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anandan C, Nurmatov U, van Schayck OC, Sheikh A. Is the prevalence of asthma declining? Systematic review of epidemiological studies. Allergy. 2010 Feb;65(2):152-67. doi: 10.1111/j.1398-9995.2009.02244.x. Epub 2009 Nov 12.
PubMed 19912154Mukherjee M, Gupta R, Farr A, Heaven M, Stoddart A, Nwaru BI, Fitzsimmons D, Chamberlain G, Bandyopadhyay A, Fischbacher C, Dibben C, Shields M, Phillips C, Strachan D, Davies G, McKinstry B, Sheikh A; Burden and True Cost of Asthma in the UK Research Team. Estimating the incidence, prevalence and true cost of asthma in the UK: secondary analysis of national stand-alone and linked databases in England, Northern Ireland, Scotland and Wales-a study protocol. BMJ Open. 2014 Nov 4;4(11):e006647. doi: 10.1136/bmjopen-2014-006647.
PubMed 25371419Jones RL, Nzekwu MM. The effects of body mass index on lung volumes. Chest. 2006 Sep;130(3):827-33. doi: 10.1378/chest.130.3.827.
PubMed 16963682Beuther DA, Weiss ST, Sutherland ER. Obesity and asthma. Am J Respir Crit Care Med. 2006 Jul 15;174(2):112-9. doi: 10.1164/rccm.200602-231PP. Epub 2006 Apr 20.
PubMed 16627866von Mutius E, Schwartz J, Neas LM, Dockery D, Weiss ST. Relation of body mass index to asthma and atopy in children: the National Health and Nutrition Examination Study III. Thorax. 2001 Nov;56(11):835-8. doi: 10.1136/thorax.56.11.835.
PubMed 11641506Colak Y, Afzal S, Lange P, Nordestgaard BG. Obese individuals experience wheezing without asthma but not asthma without wheezing: a Mendelian randomisation study of 85,437 adults from the Copenhagen General Population Study. Thorax. 2016 Mar;71(3):247-54. doi: 10.1136/thoraxjnl-2015-207379. Epub 2015 Oct 26.
PubMed 26504195Sulit LG, Storfer-Isser A, Rosen CL, Kirchner HL, Redline S. Associations of obesity, sleep-disordered breathing, and wheezing in children. Am J Respir Crit Care Med. 2005 Mar 15;171(6):659-64. doi: 10.1164/rccm.200403-398OC. Epub 2004 Dec 10.
PubMed 15591475Forno E, Weiner DJ, Mullen J, Sawicki G, Kurland G, Han YY, Cloutier MM, Canino G, Weiss ST, Litonjua AA, Celedon JC. Obesity and Airway Dysanapsis in Children with and without Asthma. Am J Respir Crit Care Med. 2017 Feb 1;195(3):314-323. doi: 10.1164/rccm.201605-1039OC.
PubMed 27552676
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Asthma in Subjects With Obstructive Sleep Apnoea (OSA) Due to Dysanapsis
- ClinicalTrials.gov ID
- NCT04142905
- Acronym / sponsor ID
- 269072
- Conditions
- Asthma, Obstructive Sleep Apnoea (OSA), Dysanapis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 29 Oct 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.
Intention to review patient letters from sleep clinic to see if their lung function fit in with Dysynapsis in wheezing patients or if it is true asthma
Detailed description
There is no evidence that the World Wide prevalence of asthma is declining. There is some evidence that this Western disease may give the appearance of declining prevalence due to improved healthcare. However evidence from the Office of National Statistics suggests that the mortality rate for asthma may be increasing year on since 2007 until 2017. The true burden of asthma in the United Kingdom is difficult to ascertain.
Obesity has effects on lung function which lead to low functional residual capacity and low end reserve volume. This leads to rapid shallow breaths near to the airway closing pressure and lung closing volume as illustrated in this review. This suggests that obesity itself may be a source of breathlessness.
High Body Mass Index (BMI) has been shown to be associated with asthma. It was also associated with wheeze that is not asthma. This finding suggests that obesity in itself may be linked to wheeze which is not asthma. It has been shown in children that sleep disordered breathing is associated with asthma as well as wheeze. Obese children are known to display dysanapsis (airway cross sectional area is small for the size of the lung) whether associated with or without asthma, however if associated with asthma, the severity of asthma can be worse.
AIM: To investigate if asthma is truly associated with Sleep disordered breathing in adult subjects. To investigate if there is an association of wheeze with dysanapsis in patients with sleep disordered breathing
NULL HYPOTHESIS: There is no difference between subjects who have sleep disordered breathing with asthma and those subjects who have sleep disordered breathing without asthma, with respect to lung function parameters.
Methods
Initially the investigators' aim is to interrogate clinical records and look at lung function testing in subjects with and without asthma who attend the sleep disordered breathing clinic. The investigators intend to investigate 100 with asthma in the sleep clinic and 100 without asthma in the sleep clinic. The Investigators will also look at eosinophil results of those with asthma compared to those without asthma and any markers of atopy.
The investigators will use Statistical Package for the Social Sciences (SPSS) to undertake simple frequency analysis and cross tabs as well as odds ratio from binary logistic regression.
References - Refer to References Section
Appendix 1
Data Collection Sheet for those with confirmed diagnosis of Obstructive sleep apnoea
Name and Date of Birth and details
Age
Weight ______Height___________Body Mass Index _________Gender at birth ___Male____Female___ Asthma diagnosis made by General Practitioner or Respiratory physician or no diagnosis of asthma (circle correct)
DATE of Test ___/___/___FEV1_______FEV1%_______
FVC_________FVC%__________
DATE of Test ___/___/___FEV1_______FEV1%_______
FVC_________FVC%__________
Dysanapsis FEV1/FVC <0.8 Yes/No FEV1/FVC <0.7 Yes/No (circle correct)
AHI/hr 5-15 16-29 >30 (circle correct)
Eosinophil count MAX in past 12 months________x109/L MAX ever ______ x109/L
DATE________
RAST test positive for which antigens
Smoking history start age________________ Pack years________________
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients With Asthma | – | –Subjects with sleep disordered breathing with asthma |
| Patients Without Asthma | – | –Subjects with sleep disordered breathing without asthma |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients attending the Obstructive Sleep Apnea Clinic at Norfolk \& Norwich University Hospital NHS Foundation Trust
Key inclusion criteria (1 listed)
- Any subject in Obstructive Sleep Apnea clinic.
Key exclusion criteria (1 listed)
- Only exclusion criteria is if they have no recorded lung function in their notes
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
Defined dysynapsis in patients with asthma and obstructive sleep apnoea (OSA)
Time frame: 6 years
The investigator will refer to the Sleep Disordered Breathing Clinic records to investigate the prevalence of dysanapsis in patients with Sleep disordered breathing, in patients with asthma compared to those without asthma.
2 secondary outcomes
Apnea-Hypopnea Index (AHI)
Time frame: 6 years
Eosinophil count
Time frame: 6 years
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 9 Jun 2026.
- Background: PubMed 19912154Anandan C, Nurmatov U, van Schayck OC, Sheikh A. Is the prevalence of asthma declining? Systematic review of epidemiological studies. Allergy. 2010 Feb;65(2):152-67. doi: 10.1111/j.1398-9995.2009.02244.x. Epub 2009 Nov 12.
- Background: PubMed 25371419Mukherjee M, Gupta R, Farr A, Heaven M, Stoddart A, Nwaru BI, Fitzsimmons D, Chamberlain G, Bandyopadhyay A, Fischbacher C, Dibben C, Shields M, Phillips C, Strachan D, Davies G, McKinstry B, Sheikh A; Burden and True Cost of Asthma in the UK Research Team. Estimating the incidence, prevalence and true cost of asthma in the UK: secondary analysis of national stand-alone and linked databases in England, Northern Ireland, Scotland and Wales-a study protocol. BMJ Open. 2014 Nov 4;4(11):e006647. doi: 10.1136/bmjopen-2014-006647.
- Background: PubMed 16963682Jones RL, Nzekwu MM. The effects of body mass index on lung volumes. Chest. 2006 Sep;130(3):827-33. doi: 10.1378/chest.130.3.827.
- Background: PubMed 16627866Beuther DA, Weiss ST, Sutherland ER. Obesity and asthma. Am J Respir Crit Care Med. 2006 Jul 15;174(2):112-9. doi: 10.1164/rccm.200602-231PP. Epub 2006 Apr 20.
- Background: PubMed 11641506von Mutius E, Schwartz J, Neas LM, Dockery D, Weiss ST. Relation of body mass index to asthma and atopy in children: the National Health and Nutrition Examination Study III. Thorax. 2001 Nov;56(11):835-8. doi: 10.1136/thorax.56.11.835.
- Background: PubMed 26504195Colak Y, Afzal S, Lange P, Nordestgaard BG. Obese individuals experience wheezing without asthma but not asthma without wheezing: a Mendelian randomisation study of 85,437 adults from the Copenhagen General Population Study. Thorax. 2016 Mar;71(3):247-54. doi: 10.1136/thoraxjnl-2015-207379. Epub 2015 Oct 26.
- Background: PubMed 15591475Sulit LG, Storfer-Isser A, Rosen CL, Kirchner HL, Redline S. Associations of obesity, sleep-disordered breathing, and wheezing in children. Am J Respir Crit Care Med. 2005 Mar 15;171(6):659-64. doi: 10.1164/rccm.200403-398OC. Epub 2004 Dec 10.
- Background: PubMed 27552676Forno E, Weiner DJ, Mullen J, Sawicki G, Kurland G, Han YY, Cloutier MM, Canino G, Weiss ST, Litonjua AA, Celedon JC. Obesity and Airway Dysanapsis in Children with and without Asthma. Am J Respir Crit Care Med. 2017 Feb 1;195(3):314-323. doi: 10.1164/rccm.201605-1039OC.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Asthma and Obstructive Sleep Apnoea (OSA), run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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 9 Jun 2026. 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 Kingdom. 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?
Defined dysynapsis in patients with asthma and obstructive sleep apnoea (OSA) (time frame: 6 years). 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 NCT04142905, which also lists 8 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 9 Jun 2026.