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AsthmaSPACNCT03505216

Swiss Paediatric Airway Cohort

An observational study of Asthma and Wheezing, run by University of Bern at 12 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Conditions the study is for
Asthma, Wheezing, Cough
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.

Claudia E Kuehni, Prof. contact

+41(0)316843507

claudia.kuehni@unibe.ch

12 sites in 2 countries

Switzerland11 sites, 9 recruiting
  • Children's hospital Aarau

    Aarau

    Active, not 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

    Recruiting
  • Children's hospital St. Gallen

    Sankt Gallen

    Active, not recruiting
  • Pulmonology clinic, Worb

    Worb

    Claudia Kuehni

    Claudia Kuehni

    Recruiting
  • University Children's Hospital Zurich

    Zurich

    Alexander Moeller

    Alexander Moeller

    Recruiting

Other trials in Switzerland

Austria1 site
  • Vienna Open Medical Institute

    Vienna

    Completed

Other trials in Austria

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.

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 groups in NCT03505216
Study groupRoleWhat they receive
Patient populationChildren 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.

  1. Wheeze

    Number of patients with current wheeze as measured with questionnaire

    Measured: 1 year from inclusion in SPAC study

  2. Cough apart from colds

    Number of patients with cough apart from colds as measured with questionnaires

    Measured: 1 year from inclusion in SPAC study

  3. Exercise-induced dyspnea

    Number of patients with exercise-induced dyspnea as measured with questionnaires

    Measured: 1 year from inclusion in SPAC study

  4. 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)
  1. Wheeze

    Number of patients with current wheeze as measured with questionnaire

    Measured: 5 years from inclusion in SPAC study

  2. Cough apart from colds

    Number of patients with Cough apart from colds as measured with questionnaire

    Measured: 5 years from inclusion in SPAC study

  3. Exercise-induced dyspnea

    Number of patients with Exercise-induced dyspnea as measured with questionnaire

    Measured: 5 years from inclusion in SPAC study

  4. 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.

  1. First posted23 Apr 2018
  2. Study start6 Jun 2017
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Jun 2030 (estimated)

Resources

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)
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.

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.

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Swiss Paediatric Airway Cohort (NCT03505216) | AzTrials