Bronchial AsthmaNCT01084317
Evaluation of the Delay in Asthma Diagnosis in Children From the Lodz Region
An observational study of Bronchial Asthma, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The aim of the research is to assess the duration of a delay in asthma diagnosis in children after the Program for Prevention of Allergic Diseases. Risk factors for delayed diagnosis of asthma in children will also be assessed. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- medical documentation and telephone interview
- How many people
- 907 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2010to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients under 18 age, with newly diagnosed asthma,
Who may be able to join
- patients under 18 age, with newly diagnosed asthma
Who cannot join
- patients under 18 age, without newly diagnosed asthma
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Social and Preventive Medicine, Medical University of Lodz, Poland, Department of Pediatrics and Allergy, N. Copernicus Hospital, Medical University of Lodz, Poland
Lodz, 93-513
About this study
Official title: Evaluation of the Delay in Asthma Diagnosis in Children From the Lodz Region After the Program for Prevention of Allergic Diseases
The aim of the research is to assess the duration of a delay in asthma diagnosis in children after the Program for Prevention of Allergic Diseases. Risk factors for delayed diagnosis of asthma in children will also be assessed. This study will answer the question of whether this ratio depends on the time, which indirectly proves that it can be changed by local intervention programs. Prove lasting effects of the Program may contribute to planning further local interventions focused on improving medical care for patients with bronchial asthma in the Lodz region, and reduce social costs associated with this disease.
Read the detailed description
The object of this study is asthma, the most common chronic childhood disease. The disease has become epidemic in developed countries and also in Poland. The percentage of children suffering from bronchial asthma in Lodz is one of the highest in the country (8.5%. Bronchial asthma in children of Lodz is a real challenge not only for doctors but also for public health professionals. This study is to assess the long-term effects of innovation on a national scale Prevention Program of Allergic Diseases, which was carried out in 2000-2003 in the region of Lodz. This Program has given many positive effects, most of all, improvement in the diagnosis of allergic diseases, availability of medical specialists and reduction the number of hospitalizations because of the disease exacerbation.
The aim of the research is to assess the duration of a delay in asthma diagnosis in children after the Program for Prevention of Allergic Diseases. Risk factors for delayed diagnosis of asthma in children will also be assessed. This study will answer the question of whether this ratio depends on the time, which indirectly proves that it can be changed by local intervention programs. Prove lasting effects of the Program may contribute to planning further local interventions focused on improving medical care for patients with bronchial asthma in the Lodz region, and reduce social costs associated with this disease.
Subject of study are patients under 18 age, with newly diagnosed asthma, who were under care in Allergy Clinic in Copernicus Hospital in Lodz in 2004-2009. Selected clinic is the largest pediatric allergy center in the region and was also the largest center participating in the Program for Prevention of Allergic Diseases and the only center, which analyzed the delay in asthma diagnosis among patients. Children's medical documentation will be analyzed as far as following data were concerned: demographic data, anthropometric parameters, information about family history of atopic diseases, asthma symptoms (cough, dyspnoea, wheezing, reducing physical activity, and recurrent respiratory infections) and symptoms of other atopic diseases in both the current and in the past. In addition, information will be collected on the child's family situation, housing conditions and the presence of animals in the house. Data obtained from the children's medical documentation will be supplemented by telephone interview conducted with parents of the child. The group of patients with underdiagnosed asthma will be classified as children who experienced frequent wheezing (at least 4 episodes per year) and 1 major criterium (positive family history of allergic diseases or symptoms of atopic as infants) or two smaller criteria (symptoms of food allergies, the increased number of eosinophilic cells in the peripheral blood or wheezing without infection). For each child the time from appearance of asthma symptoms (according to the API - asthma predictive index) to diagnose the disease by a specialist will be set. This time will be defined as duration of undiagnosed asthma. Due to the fact that the delay in asthma diagnosis is dependent on the patient's age, the analysis will be carried out in four groups separated on the basis of the upper and lower quartiles of respondents age.
- Conditions
- Bronchial Asthma
- Being tested
- medical documentation and telephone interview
- Keywords
- asthma, children, delay in asthma diagnosis
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical documentation and telephone interviewOther
medical documentation analysis supplemented by telephone interview conducted with parents of the child
| Study group | Role | What they receive |
|---|---|---|
| asthmatic children | patients under 18 age, with newly diagnosed asthma Receives: Other: medical documentation and telephone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of a delay in asthma diagnosis in children
The duration of a delay in asthma diagnosis in children after the Program for Prevention of Allergic Diseases
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 907 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Stelmach, Medical University of Lodz
- Investigators
- Włodzimierz Stelmach, MD, PhD, Study chair, Department of Social and Preventive Medicine, Medical University of Lodz, PolandIwona Stelmach, MD,PhD,Prof., Study director, Department of Pediatrics and Allergy, N. Copernicus Hospital, Medical University of Lodz, PolandEwa Bąk, Master of Sc, Principal investigator, Department of Social and Preventive Medicine, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084317
- Sponsor's protocol ID
- RNN/603/09/KB
- Status last verified
- Feb 2013
- First submitted
- 9 Mar 2010
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Delay in Asthma Diagnosis in Children From the Lodz Region After the Program for Prevention of Allergic Diseases
- ClinicalTrials.gov ID
- NCT01084317
- Acronym / sponsor ID
- RNN/603/09/KB
- Conditions
- Bronchial Asthma
- Keywords
- asthma, children, delay in asthma diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 907 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the research is to assess the duration of a delay in asthma diagnosis in children after the Program for Prevention of Allergic Diseases. Risk factors for delayed diagnosis of asthma in children will also be assessed. This study will answer the question of whether this ratio depends on the time, which indirectly proves that it can be changed by local intervention programs. Prove lasting effects of the Program may contribute to planning further local interventions focused on improving medical care for patients with bronchial asthma in the Lodz region, and reduce social costs associated with this disease.
Detailed description
The object of this study is asthma, the most common chronic childhood disease. The disease has become epidemic in developed countries and also in Poland. The percentage of children suffering from bronchial asthma in Lodz is one of the highest in the country (8.5%. Bronchial asthma in children of Lodz is a real challenge not only for doctors but also for public health professionals. This study is to assess the long-term effects of innovation on a national scale Prevention Program of Allergic Diseases, which was carried out in 2000-2003 in the region of Lodz. This Program has given many positive effects, most of all, improvement in the diagnosis of allergic diseases, availability of medical specialists and reduction the number of hospitalizations because of the disease exacerbation.
The aim of the research is to assess the duration of a delay in asthma diagnosis in children after the Program for Prevention of Allergic Diseases. Risk factors for delayed diagnosis of asthma in children will also be assessed. This study will answer the question of whether this ratio depends on the time, which indirectly proves that it can be changed by local intervention programs. Prove lasting effects of the Program may contribute to planning further local interventions focused on improving medical care for patients with bronchial asthma in the Lodz region, and reduce social costs associated with this disease.
Subject of study are patients under 18 age, with newly diagnosed asthma, who were under care in Allergy Clinic in Copernicus Hospital in Lodz in 2004-2009. Selected clinic is the largest pediatric allergy center in the region and was also the largest center participating in the Program for Prevention of Allergic Diseases and the only center, which analyzed the delay in asthma diagnosis among patients. Children's medical documentation will be analyzed as far as following data were concerned: demographic data, anthropometric parameters, information about family history of atopic diseases, asthma symptoms (cough, dyspnoea, wheezing, reducing physical activity, and recurrent respiratory infections) and symptoms of other atopic diseases in both the current and in the past. In addition, information will be collected on the child's family situation, housing conditions and the presence of animals in the house. Data obtained from the children's medical documentation will be supplemented by telephone interview conducted with parents of the child. The group of patients with underdiagnosed asthma will be classified as children who experienced frequent wheezing (at least 4 episodes per year) and 1 major criterium (positive family history of allergic diseases or symptoms of atopic as infants) or two smaller criteria (symptoms of food allergies, the increased number of eosinophilic cells in the peripheral blood or wheezing without infection). For each child the time from appearance of asthma symptoms (according to the API - asthma predictive index) to diagnose the disease by a specialist will be set. This time will be defined as duration of undiagnosed asthma. Due to the fact that the delay in asthma diagnosis is dependent on the patient's age, the analysis will be carried out in four groups separated on the basis of the upper and lower quartiles of respondents age.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| asthmatic children | – | Other: medical documentation and telephone interviewpatients under 18 age, with newly diagnosed asthma |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients under 18 age, with newly diagnosed asthma,
Key inclusion criteria (1 listed)
- patients under 18 age, with newly diagnosed asthma
Key exclusion criteria (1 listed)
- patients under 18 age, without newly diagnosed asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical documentation and telephone interviewmedical documentation analysis supplemented by telephone interview conducted with parents of the child | Other | asthmatic children |
Primary outcome
duration of a delay in asthma diagnosis in children
Time frame: 5 years
The duration of a delay in asthma diagnosis in children after the Program for Prevention of Allergic Diseases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
Related trials for Bronchial Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Włodzimierz Stelmach, MD, PhD study chair
Department of Social and Preventive Medicine, Medical University of Lodz, Poland
Iwona Stelmach, MD,PhD,Prof. study director
Department of Pediatrics and Allergy, N. Copernicus Hospital, Medical University of Lodz, Poland
Ewa Bąk, Master of Sc principal investigator
Department of Social and Preventive Medicine, Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by Medical University of Lodz at 1 site in Poland.
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 1 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: finished, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of a delay in asthma diagnosis in children (time frame: 5 years). 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 7 Feb 2013.