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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03505216
Other study ID # SPAC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 6, 2017
Est. completion date June 1, 2030

Study information

Verified date October 2023
Source University of Bern
Contact Claudia E Kuehni, Prof.
Phone +41(0)316843507
Email claudia.kuehni@unibe.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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/


Description:

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Study Design


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Sponsors (1)

Lead Sponsor Collaborator
University of Bern

Countries where clinical trial is conducted

Austria,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wheeze Number of patients with current wheeze as measured with questionnaire 1 year from inclusion in SPAC study
Primary Cough apart from colds Number of patients with cough apart from colds as measured with questionnaires 1 year from inclusion in SPAC study
Primary Exercise-induced dyspnea Number of patients with exercise-induced dyspnea as measured with questionnaires 1 year from inclusion in SPAC study
Primary 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 Wheeze Number of patients with current wheeze as measured with questionnaire 5 years from inclusion in SPAC study
Secondary Cough apart from colds Number of patients with Cough apart from colds as measured with questionnaire 5 years from inclusion in SPAC study
Secondary Exercise-induced dyspnea Number of patients with Exercise-induced dyspnea as measured with questionnaire 5 years from inclusion in SPAC study
Secondary 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, 5 years from inclusion in SPAC study
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