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RecruitingNCT03505216SPACUpdated Apr 21, 2026

Swiss Paediatric Airway Cohort

An observational study in Asthma, Wheezing and Cough, sponsored by University of Bern. Recruiting at 12 sites in 2 countries. Open to participants aged 0 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by University of Bern · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,000
Ages
0 Years to 16 Years
Sex
All
01

Study 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. 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/

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.

02

Conditions studied

  • Asthma
  • Wheezing
  • Cough
  • Exercise Induced Bronchospasm
  • Inspiratory Laryngeal Obstruction
  • Dysfunctional Breathing
03

Who can participate

Ages eligible
0 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Paediatric pulmonology outpatient clinics in Switzerland

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

Prior diagnosis of cystic fibrosis, primary ciliary dyskinesia, severe heart disease, oncological disease, neuromuscular disease or severe disability

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient population

    Children referred to paediatric pulmonary outpatient clinics for respiratory symptoms such as wheeze, cough, dyspnea, exercise- and sleep-related breathing problems.

05

What researchers measure

Primary outcomes

  1. Wheeze

    Number of patients with current wheeze as measured with questionnaire

    Time frame: 1 year from inclusion in SPAC study

  2. Cough apart from colds

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

    Time frame: 1 year from inclusion in SPAC study

  3. Exercise-induced dyspnea

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

    Time frame: 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.

    Time frame: 1 year from inclusion in SPAC study

Secondary outcomes

  1. Wheeze

    Number of patients with current wheeze as measured with questionnaire

    Time frame: 5 years from inclusion in SPAC study

  2. Cough apart from colds

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

    Time frame: 5 years from inclusion in SPAC study

  3. Exercise-induced dyspnea

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

    Time frame: 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,

    Time frame: 5 years from inclusion in SPAC study

06

Study locations

9 of 12 sites recruiting
  • Vienna Open Medical Institute
    Vienna, Austria
    Completed
  • Children's hospital Aarau
    Aarau, Switzerland
    Active, not recruiting
  • University Children's hospital Basel, UKBB
    Basel, Switzerland
    • Anja Jochmann · Contact
    • Anja Jochmann · Principal investigator
    Recruiting
  • Institute of Social and Preventive Medicine
    Bern, 3012, Switzerland
    • Claudia E Kuehni, Prof · Contact
    • Claudia E Kuehni, Prof · Principal investigator
    Recruiting
  • University Children's Hospital Bern, Inselspital
    Bern, Switzerland
    • Philipp Latzin · Contact
    • Philipp Latzin · Principal investigator
    • Florian Singer · Sub investigator
    Recruiting
  • Children's Hospital Chur
    Chur, Switzerland
    • Peter Iseli · Contact
    • Peter Iseli · Principal investigator
    Recruiting
  • Pulmonology clinic, Horgen
    Horgen, Switzerland
    • Karin Hoyler · Contact
    • Karin Hoyler · Principal investigator
    Recruiting
  • University Children's hospital Lausane, CHUV
    Lausanne, Switzerland
    • Sylvain Blanchon · Contact
    • Sylvain Blanchon · Principal investigator
    • Isabelle Rochat · Sub investigator
    Recruiting
  • Children's hospital Lucerne
    Lucerne, Switzerland
    • Nicolas Regamey · Contact
    • Nicolas Regamey · Principal investigator
    Recruiting
  • Children's hospital St. Gallen
    Sankt Gallen, Switzerland
    Active, not recruiting
  • Pulmonology clinic, Worb
    Worb, Switzerland
    • Claudia Kuehni · Contact
    • Claudia Kuehni · Principal investigator
    Recruiting
  • University Children's Hospital Zurich
    Zurich, Switzerland
    • Alexander Moeller · Contact
    • Alexander Moeller · Principal investigator
    Recruiting
07

References and documents

Related links

Individual participant data

Plan to share: 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.

08

Registry details

Key details

Study ID
NCT03505216
Lead sponsor
University of Bern
Responsible party
Sponsor
First posted
Apr 23, 2018
Start date
Jun 6, 2017
Primary completion
Sep 1, 2026 (estimated)
Completion
Jun 1, 2030 (estimated)
Last update
Apr 21, 2026

Study contacts

Claudia E Kuehni, Prof.
Contact
claudia.kuehni@unibe.ch
+41(0)316843507
Claudia E Kuehni, Prof.
study director · Institute of Social and Preventive Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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