NCT03505216

Brief 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/

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
2 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jun 2017Jun 2030

Study Start

First participant enrolled

June 6, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

9.2 years

First QC Date

April 2, 2018

Last Update Submit

April 16, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Wheeze

    Number of patients with current wheeze as measured with questionnaire

    1 year from inclusion in SPAC study

  • Cough apart from colds

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

    1 year from inclusion in SPAC study

  • Exercise-induced dyspnea

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

    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.

    1 year from inclusion in SPAC study

Secondary Outcomes (4)

  • Wheeze

    5 years from inclusion in SPAC study

  • Cough apart from colds

    5 years from inclusion in SPAC study

  • Exercise-induced dyspnea

    5 years from inclusion in SPAC study

  • Reduced lung function

    5 years from inclusion in SPAC study

Study Arms (1)

Patient population

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

Eligibility Criteria

Age0 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Paediatric pulmonology outpatient clinics in Switzerland

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Vienna Open Medical Institute

Vienna, Austria

COMPLETED

Children's hospital Aarau

Aarau, Switzerland

ACTIVE NOT RECRUITING

University Children's hospital Basel, UKBB

Basel, Switzerland

RECRUITING

Institute of Social and Preventive Medicine

Bern, 3012, Switzerland

RECRUITING

University Children's Hospital Bern, Inselspital

Bern, Switzerland

RECRUITING

Children's Hospital Chur

Chur, Switzerland

RECRUITING

Pulmonology clinic, Horgen

Horgen, Switzerland

RECRUITING

University Children's hospital Lausane, CHUV

Lausanne, Switzerland

RECRUITING

Children's hospital Lucerne

Lucerne, Switzerland

RECRUITING

Children's hospital St. Gallen

Sankt Gallen, Switzerland

ACTIVE NOT RECRUITING

Pulmonology clinic, Worb

Worb, Switzerland

RECRUITING

University Children's Hospital Zurich

Zurich, Switzerland

RECRUITING

Related Links

MeSH Terms

Conditions

AsthmaRespiratory SoundsCoughAsthma, Exercise-Induced

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersExercise-Induced Allergies

Study Officials

  • Claudia E Kuehni, Prof.

    Institute of Social and Preventive Medicine

    STUDY DIRECTOR

Central Study Contacts

Claudia E Kuehni, Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 23, 2018

Study Start

June 6, 2017

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

June 1, 2030

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Locations