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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Poland

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.

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 groups in NCT01084317
Study groupRoleWhat they receive
asthmatic childrenpatients 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.

  1. 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.

  1. First posted10 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Resources

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)
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

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.

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