AsthmaSPACNCT03505216
Swiss Paediatric Airway Cohort
An observational study of Asthma and Wheezing, run by University of Bern at 12 sites in 2 countries.
Trial summary
The Swiss Paediatric Airway Cohort (SPAC) is a national, prospective clinical cohort of children and adolescents who visit physicians in Switzerland for recurrent wheeze, cough, and exercise- or sleep-related respiratory problems. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- How many people
- 6,000 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 6 Jun 2017to 1 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Paediatric pulmonology outpatient clinics in Switzerland
Who may be able to join
- Children and adolescents aged 0-16 years
- Resident in Switzerland
- Seen in a paediatric pulmonary outpatient clinic due to respiratory problems
- Parents and patients above age 14 must be able to sign an informed consent form
Who cannot join
- Prior diagnosis of cystic fibrosis, primary ciliary dyskinesia, severe heart disease, oncological disease, neuromuscular disease or severe disability
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 2 countries
Switzerland11 sites, 9 recruiting
- Active, not recruiting
Children's hospital Aarau
Aarau
- Recruiting
University Children's hospital Basel, UKBB
Basel
Anja Jochmann
Anja Jochmann
- Recruiting
Institute of Social and Preventive Medicine
Bern, 3012
Claudia E Kuehni, Prof
Claudia E Kuehni, Prof
- Recruiting
University Children's Hospital Bern, Inselspital
Bern
Philipp Latzin
Philipp Latzin
- Recruiting
Children's Hospital Chur
Chur
Peter Iseli
Peter Iseli
- Recruiting
Pulmonology clinic, Horgen
Horgen
Karin Hoyler
Karin Hoyler
- Recruiting
University Children's hospital Lausane, CHUV
Lausanne
Sylvain Blanchon
Sylvain Blanchon
- Recruiting
Children's hospital Lucerne
Lucerne
Nicolas Regamey
Nicolas Regamey
- Active, not recruiting
Children's hospital St. Gallen
Sankt Gallen
- Recruiting
Pulmonology clinic, Worb
Worb
Claudia Kuehni
Claudia Kuehni
- Recruiting
University Children's Hospital Zurich
Zurich
Alexander Moeller
Alexander Moeller
About this study
The Swiss Paediatric Airway Cohort (SPAC) is a national, prospective clinical cohort of children and adolescents who visit physicians in Switzerland for recurrent wheeze, cough, and exercise- or sleep-related respiratory problems. SPAC aims to answer important questions on clinical phenotypes, prognosis, diagnosis and treatment. SPAC is part of routine care, and only clinically indicated investigations are done. The comprehensive baseline assessment includes a detailed questionnaire to families, plus test results, diagnoses and treatments from hospital records. Follow-up is via monthly questionnaires the first 12 months and thereafter annual questionnaires to families, and data from follow-up visits.
Currently, 4344 patients from 10 clinics and hospitals in Switzerland (Aarau, Basel, Bern, Chur, Horgen, Lausanne, Luzern, St. Gallen, Worb, Zurich) have been enrolled.
Read more
SPAC provides real-life data on children visiting the Swiss health care system for common respiratory problems. It will provide a research platform for health services research, and for nested clinical and transitional studies.
Publications and plain language summaries are listed on the study website: https://www.spac-study.ch/publikationen/
Read the detailed description
Background:
Many studies have investigated the epidemiology of asthma in childhood, but most were based on data from the general population gathered either in cross-sectional or longitudinal surveys in schoolchildren.
Objectives:
The Swiss Paediatric Airway Cohort (SPAC) was set up in 2017 as a large, longitudinal database that is representative of children and adolescents visiting physicians in Switzerland for recurrent wheeze, cough, and exercise- or sleep-related respiratory symptoms. It will constitute a national research platform for studying healthcare provision, phenotypes and prognosis of these problems, and a sampling frame for conducting nested studies.
Methods:
Recruitment and participation:
The SPAC study recruits patients aged 0-16 that are referred to a paediatric outpatient clinic for recurrent respiratory symptoms. Families receive a SPAC information package containing an invitation letter, study information leaflet, informed consent form, and questionnaire. Physicians introduce the study to them, answer questions, and collect informed consent forms. Completed questionnaires are brought by families to the clinics or sent directly by families to the SPAC study centre using a prepaid return envelope. Eligible patients have consultations in participating clinics regardless of their study participation. No tests are performed specifically for SPAC; examinations and tests are done only if clinically indicated or ordered by the referring physician. Examinations such as lung function, allergy, blood, or bronchial challenge tests are done using respective standard procedures in the clinics. SPAC research team members visit participating centres at regular intervals to collect data. During the first year, caregivers or patients who are 14 years or older receive short online questionnaire through a link via email. One year after enrolment and each year thereafter, caregivers receive a follow-up questionnaire by post.
Information collected:
Questionnaires:
At baseline families complete a detailed questionnaire that includes sections on frequency, duration, severity, triggers, and history of upper and lower respiratory symptoms, and diagnoses, treatments, health behaviours, environmental factors, family history, and contact information. The monthly online questionnaires focus on symptoms, infections, and treatments which may change short-term. The yearly follow-up questionnaires focus on symptoms, treatments, and important risk factors during the past 12 months. Postal addresses for mailing are obtained from hospital records and updated by contacting community registration offices, a procedure used successfully for other registries and cohort studies in Switzerland. Questionnaires are currently available in German and French.
Medical records:
Information obtained from medical records includes reasons for referral; anthropometric measures; results from the physical examination and diagnostic tests including pulmonary function, allergy, and blood tests; information about asthma control; and final diagnoses and prescribed treatments.
Linkage to routine data:
For specific analyses, probabilistic record linkage will be used to merge data from SPAC with routine datasets collected by the Swiss Federal Statistical Office.
Study database:
The SPAC database is web-based, using the Research Electronic Data Capture (REDCap) platform developed at Vanderbilt University. REDCap is widely used in academic research and allows data entry and extraction in various formats.
Current status of the project:
SPAC recruits participants from 10 clinics in Switzerland including the children's hospital in Aarau, the University Children's hospital in Basel, the University Children's Hospital in Bern, the Children's hospital in Chur, a private paediatric pulmonology clinic in Horgen, the University Children's hospital in Lausanne, the Children's hospital in Luzern, the Children's hospital in St. Gallen, a private paediatric pulmonology clinic in Worb, and the University Children's Hospital in Zurich. By October 2023, 4344 children have agreed to participate in SPAC.
Publications and plain language summaries are listed on the study website: https://www.spac-study.ch/publikationen/
Funding:
Setting up SPAC was funded by the Swiss National Science Foundation (SNF32003B_162820, SNF320030_182628, SNF320030_212519), and several local funding bodies including the Swiss Lung Association, the Lung League of St. Gallen, and the Allergiestiftung Ulrich Müller-Gierok.
- Conditions
- Asthma, Wheezing, Cough, Exercise Induced Bronchospasm, Inspiratory Laryngeal Obstruction, Dysfunctional Breathing
- Medical subject headings
- Asthma, Respiratory Sounds, Cough, Asthma, Exercise-Induced
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 |
|---|---|---|
| Patient population | Children referred to paediatric pulmonary outpatient clinics for respiratory symptoms such as wheeze, cough, dyspnea, exercise- and sleep-related breathing problems. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheeze
Number of patients with current wheeze as measured with questionnaire
Measured: 1 year from inclusion in SPAC study
Cough apart from colds
Number of patients with cough apart from colds as measured with questionnaires
Measured: 1 year from inclusion in SPAC study
Exercise-induced dyspnea
Number of patients with exercise-induced dyspnea as measured with questionnaires
Measured: 1 year from inclusion in SPAC study
Reduced lung function
Number of patients with reduced lung function measured through clinical tests in the paediatric pulmonary clinics (Spirometry, Fraction of Exhaled Nitric Oxide, Bronchial challenge test, Exercise challenge test). Information collected through hospital records.
Measured: 1 year from inclusion in SPAC study
Secondary outcomes (4)
Wheeze
Number of patients with current wheeze as measured with questionnaire
Measured: 5 years from inclusion in SPAC study
Cough apart from colds
Number of patients with Cough apart from colds as measured with questionnaire
Measured: 5 years from inclusion in SPAC study
Exercise-induced dyspnea
Number of patients with Exercise-induced dyspnea as measured with questionnaire
Measured: 5 years from inclusion in SPAC study
Reduced lung function
Number of patients with reduced lung function measured through clinical tests in the paediatric pulmonary clinics (Spirometry, Fraction of Exhaled Nitric Oxide,
Measured: 5 years from inclusion in SPAC study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start6 Jun 2017
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia E Kuehni, Prof., Study director, Institute of Social and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505216
- Sponsor's protocol ID
- SPAC
- Acronym
- SPAC
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2018
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers who wish to develop a nested study with inclusion of additional data also need to submit a proposal to the SPAC committee and request permission. A concept sheet describing the planned analyses must be approved by the SPAC committee. If any additional data are collected by nested studies, these must be contributed to the SPAC database after the data collection. Nested studies might need separate ethics permission. At the study website: www.spac-study.ch, information can be found on how to request permission to use data from the SPAC study.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Paediatric Airway Cohort
- ClinicalTrials.gov ID
- NCT03505216
- Acronym / sponsor ID
- SPAC / SPAC
- Conditions
- Asthma, Wheezing, Cough, Exercise Induced Bronchospasm, Inspiratory Laryngeal Obstruction, Dysfunctional Breathing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 23 Apr 2018 (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.
The Swiss Paediatric Airway Cohort (SPAC) is a national, prospective clinical cohort of children and adolescents who visit physicians in Switzerland for recurrent wheeze, cough, and exercise- or sleep-related respiratory problems. SPAC aims to answer important questions on clinical phenotypes, prognosis, diagnosis and treatment. SPAC is part of routine care, and only clinically indicated investigations are done. The comprehensive baseline assessment includes a detailed questionnaire to families, plus test results, diagnoses and treatments from hospital records. Follow-up is via monthly questionnaires the first 12 months and thereafter annual questionnaires to families, and data from follow-up visits.
Currently, 4344 patients from 10 clinics and hospitals in Switzerland (Aarau, Basel, Bern, Chur, Horgen, Lausanne, Luzern, St. Gallen, Worb, Zurich) have been enrolled.
SPAC provides real-life data on children visiting the Swiss health care system for common respiratory problems. It will provide a research platform for health services research, and for nested clinical and transitional studies.
Publications and plain language summaries are listed on the study website: https://www.spac-study.ch/publikationen/
Detailed description
Background:
Many studies have investigated the epidemiology of asthma in childhood, but most were based on data from the general population gathered either in cross-sectional or longitudinal surveys in schoolchildren.
Objectives:
The Swiss Paediatric Airway Cohort (SPAC) was set up in 2017 as a large, longitudinal database that is representative of children and adolescents visiting physicians in Switzerland for recurrent wheeze, cough, and exercise- or sleep-related respiratory symptoms. It will constitute a national research platform for studying healthcare provision, phenotypes and prognosis of these problems, and a sampling frame for conducting nested studies.
Methods:
Recruitment and participation:
The SPAC study recruits patients aged 0-16 that are referred to a paediatric outpatient clinic for recurrent respiratory symptoms. Families receive a SPAC information package containing an invitation letter, study information leaflet, informed consent form, and questionnaire. Physicians introduce the study to them, answer questions, and collect informed consent forms. Completed questionnaires are brought by families to the clinics or sent directly by families to the SPAC study centre using a prepaid return envelope. Eligible patients have consultations in participating clinics regardless of their study participation. No tests are performed specifically for SPAC; examinations and tests are done only if clinically indicated or ordered by the referring physician. Examinations such as lung function, allergy, blood, or bronchial challenge tests are done using respective standard procedures in the clinics. SPAC research team members visit participating centres at regular intervals to collect data. During the first year, caregivers or patients who are 14 years or older receive short online questionnaire through a link via email. One year after enrolment and each year thereafter, caregivers receive a follow-up questionnaire by post.
Information collected:
Questionnaires:
At baseline families complete a detailed questionnaire that includes sections on frequency, duration, severity, triggers, and history of upper and lower respiratory symptoms, and diagnoses, treatments, health behaviours, environmental factors, family history, and contact information. The monthly online questionnaires focus on symptoms, infections, and treatments which may change short-term. The yearly follow-up questionnaires focus on symptoms, treatments, and important risk factors during the past 12 months. Postal addresses for mailing are obtained from hospital records and updated by contacting community registration offices, a procedure used successfully for other registries and cohort studies in Switzerland. Questionnaires are currently available in German and French.
Medical records:
Information obtained from medical records includes reasons for referral; anthropometric measures; results from the physical examination and diagnostic tests including pulmonary function, allergy, and blood tests; information about asthma control; and final diagnoses and prescribed treatments.
Linkage to routine data:
For specific analyses, probabilistic record linkage will be used to merge data from SPAC with routine datasets collected by the Swiss Federal Statistical Office.
Study database:
The SPAC database is web-based, using the Research Electronic Data Capture (REDCap) platform developed at Vanderbilt University. REDCap is widely used in academic research and allows data entry and extraction in various formats.
Current status of the project:
SPAC recruits participants from 10 clinics in Switzerland including the children's hospital in Aarau, the University Children's hospital in Basel, the University Children's Hospital in Bern, the Children's hospital in Chur, a private paediatric pulmonology clinic in Horgen, the University Children's hospital in Lausanne, the Children's hospital in Luzern, the Children's hospital in St. Gallen, a private paediatric pulmonology clinic in Worb, and the University Children's Hospital in Zurich. By October 2023, 4344 children have agreed to participate in SPAC.
Publications and plain language summaries are listed on the study website: https://www.spac-study.ch/publikationen/
Funding:
Setting up SPAC was funded by the Swiss National Science Foundation (SNF32003B_162820, SNF320030_182628, SNF320030_212519), and several local funding bodies including the Swiss Lung Association, the Lung League of St. Gallen, and the Allergiestiftung Ulrich Müller-Gierok.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient population | – | –Children referred to paediatric pulmonary outpatient clinics for respiratory symptoms such as wheeze, cough, dyspnea, exercise- and sleep-related breathing problems. |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Paediatric pulmonology outpatient clinics in Switzerland
Key inclusion criteria (4 listed)
- Children and adolescents aged 0-16 years
- Resident in Switzerland
- Seen in a paediatric pulmonary outpatient clinic due to respiratory problems
- Parents and patients above age 14 must be able to sign an informed consent form
Key exclusion criteria (1 listed)
- Prior diagnosis of cystic fibrosis, primary ciliary dyskinesia, severe heart disease, oncological disease, neuromuscular disease or severe disability
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
Wheeze
Time frame: 1 year from inclusion in SPAC study
Number of patients with current wheeze as measured with questionnaire
Cough apart from colds
Time frame: 1 year from inclusion in SPAC study
Number of patients with cough apart from colds as measured with questionnaires
Exercise-induced dyspnea
Time frame: 1 year from inclusion in SPAC study
Number of patients with exercise-induced dyspnea as measured with questionnaires
Reduced lung function
Time frame: 1 year from inclusion in SPAC study
Number of patients with reduced lung function measured through clinical tests in the paediatric pulmonary clinics (Spirometry, Fraction of Exhaled Nitric Oxide, Bronchial challenge test, Exercise challenge test). Information collected through hospital records.
4 secondary outcomes
Wheeze
Time frame: 5 years from inclusion in SPAC study
Cough apart from colds
Time frame: 5 years from inclusion in SPAC study
Exercise-induced dyspnea
Time frame: 5 years from inclusion in SPAC study
Reduced lung function
Time frame: 5 years from inclusion in SPAC study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Researchers who wish to develop a nested study with inclusion of additional data also need to submit a proposal to the SPAC committee and request permission. A concept sheet describing the planned analyses must be approved by the SPAC committee. If any additional data are collected by nested studies, these must be contributed to the SPAC database after the data collection. Nested studies might need separate ethics permission. At the study website: www.spac-study.ch, information can be found on how to request permission to use data from the SPAC study.
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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.
Claudia E Kuehni, Prof. study director
Institute of Social and Preventive Medicine
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Wheezing, run by University of Bern at 12 sites in 2 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 21 Apr 2026. 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 Switzerland, Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia E Kuehni, Prof. (+41(0)316843507, claudia.kuehni@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wheeze (time frame: 1 year from inclusion in SPAC study). The study lists 4 primary outcomes in all. 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 21 Apr 2026.