ClinicalTrials.gov
ClinicalTrials.gov Menu

Swiss Paediatric Airway Cohort (SPAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03505216
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Collaborators:
University Children's Hospital, Zurich
Cantonal Hospital, Lucerne
University Children's Hospital Basel, UKBB
University Hospital Inselspital, Bern
Children's Hospital of St. Gallen
Information provided by (Responsible Party):
University of Bern

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 annual questionnaires to families, monthly mobile phone symptom scores, and data from follow-up visits.

Currently, 350 patients from four major hospitals (Bern, Zurich, Basel and Lucerne) have been enrolled, but other clinics and practices will join and the investigators aim for at least 3000 patients.

SPAC will provide 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.


Condition or disease
Asthma Wheezing Cough Exercise Induced Bronchospasm Vocal Cord Dysfunction

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Swiss Paediatric Airway Cohort
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2030

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Wheeze [ Time Frame: 1 year from inclusion in SPAC study ]
    Number of patients with current wheeze as measured with questionnaire

  2. 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

  3. Exercise-induced dyspnea [ Time Frame: 1 year from inclusion in SPAC study ]
    Number of patients with exercise-induced dyspnea as measured with questionnaires

  4. 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.


Secondary Outcome Measures :
  1. Wheeze [ Time Frame: 5 years from inclusion in SPAC study ]
    Number of patients with current wheeze as measured with questionnaire

  2. Cough apart from colds [ Time Frame: 5 years from inclusion in SPAC study ]
    Number of patients with Cough apart from colds as measured with questionnaire

  3. Exercise-induced dyspnea [ Time Frame: 5 years from inclusion in SPAC study ]
    Number of patients with Exercise-induced dyspnea as measured with questionnaire

  4. Reduced lung function [ Time Frame: 5 years 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,



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Paediatric pulmonology outpatient clinics in Switzerland
Criteria

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:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505216


Contacts
Contact: Claudia E Kuehni, Prof. +41(0)316313507 claudia.kuehni@ispm.unibe.ch

Locations
Switzerland
Institute of Social and Preventive Medicine Recruiting
Bern, Switzerland, 3012
Contact: Claudia E Kuehni, Prof         
Principal Investigator: Claudia E Kuehni, Prof         
Sponsors and Collaborators
University of Bern
University Children's Hospital, Zurich
Cantonal Hospital, Lucerne
University Children's Hospital Basel, UKBB
University Hospital Inselspital, Bern
Children's Hospital of St. Gallen
Investigators
Study Director: Claudia E Kuehni, Prof. Institute of Social and Preventive Medicine

Additional Information:
Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03505216     History of Changes
Other Study ID Numbers: SPAC
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vocal Cord Dysfunction
Respiratory Sounds
Bronchial Spasm
Asthma, Exercise-Induced
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Diseases
Asthma
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Laryngeal Diseases
Respiration Disorders
Otorhinolaryngologic Diseases