AsthmaNCT00491101
Valuation of Quality of Life in Children With Asthma
An observational study of Asthma, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The aim of the study is valuation of quality of life (QL) in children with asthma and analysis of the factors that can have influence on it. The clinical problems included into the aim are to evaluate: the correlation between the QL and asthma control the utility of the Polish Version of PAQLQ(S) by Juniper… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Polish Version of PAQLQ(S) by Juniper and spirometry
- How many people
- 110 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2007to Oct 2009
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with asthma.
Who may be able to join
- Clinical diagnosis of Asthma
- Asthma treatment at least 6 months before enrollment
- Must be able to do spirometry
Who cannot join
- Children during the introductory period of the specific immunotherapy
- Other protracted diseases
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Lodz, 93-513
About this study
The aim of the study is valuation of quality of life (QL) in children with asthma and analysis of the factors that can have influence on it. The clinical problems included into the aim are to evaluate:
- the correlation between the QL and asthma control
- the utility of the Polish Version of PAQLQ(S) by Juniper, especially the understanding of each question and it's answers The results of this study can be very helpful in the future in developing a questionnaires to use in Polish Primary Care, according to which the investigators would be able to see whether the asthma in our patients is being well controlled.
Read the detailed description
Quality of Life in people with asthma is strictly relevant with the correct treatment of the disease, that is why the correct screening of patient's quality of life, especially in children, is so important.
Exploring the quality of life (QL), we use different types of questionnaires to obtain a quantitative result, which we can interpret using a compatible key for it. Pediatric Asthma Quality of Life Questionnaire with Standardized Activities (PAQLQ(S)) by Juniper is a reliable measure of the influence of asthma on QL in children. The Polish Version of the questionnaire is a strict translation of the english one, however it is not completely validated, which in practice can evince in difficulties in understanding the meaning of the applied questions, probably because of the difference in the habits of both populations.
The aim of the study is valuation of quality of life (QL) in children with asthma and analysis of the factors that can have influence on it. The clinical problems included into the aim are to evaluate:
- the correlation between the QL and asthma control
- the utility of the Polish Version of PAQLQ(S) by Juniper, especially the understanding of each question and it's answers The results of this study can be very helpful in the future in developing a questionnaires to use in Polish Primary Care, according to which we would be able to see whether the asthma in our patients is being well controlled.
- Conditions
- Asthma
- Being tested
- Polish Version of PAQLQ(S) by Juniper, spirometry
- Keywords
- Asthma Control, Quality of Life, Children, Polish Version of PAQLQ(S) by Juniper
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polish Version of PAQLQ(S) by JuniperOther
Polish Version of PAQLQ(S) by Juniper
spirometryOther
spirometry
| Study group | Role | What they receive |
|---|---|---|
| 1 | Children with asthma, both genders, from 7-18 years old. Receives: Other: Polish Version of PAQLQ(S) by Juniper; Other: spirometry |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Investigators
- Iwona Stelmach, MD, PhD, Prof, Study chair, Department of Pediatrics and Allergy, Medical University of Lodz, PolandDaniela Gjurow, MD, Principal investigator, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491101
- Sponsor's protocol ID
- RNN-82-07-KE
- Status last verified
- Dec 2008
- First submitted
- 22 Jun 2007
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valuation of Quality of Life in Children With Asthma
- ClinicalTrials.gov ID
- NCT00491101
- Acronym / sponsor ID
- RNN-82-07-KE
- Conditions
- Asthma
- Keywords
- Asthma Control, Quality of Life, Children, Polish Version of PAQLQ(S) by Juniper
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 25 Jun 2007 (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 study is valuation of quality of life (QL) in children with asthma and analysis of the factors that can have influence on it. The clinical problems included into the aim are to evaluate:
- the correlation between the QL and asthma control
- the utility of the Polish Version of PAQLQ(S) by Juniper, especially the understanding of each question and it's answers The results of this study can be very helpful in the future in developing a questionnaires to use in Polish Primary Care, according to which the investigators would be able to see whether the asthma in our patients is being well controlled.
Detailed description
Quality of Life in people with asthma is strictly relevant with the correct treatment of the disease, that is why the correct screening of patient's quality of life, especially in children, is so important.
Exploring the quality of life (QL), we use different types of questionnaires to obtain a quantitative result, which we can interpret using a compatible key for it. Pediatric Asthma Quality of Life Questionnaire with Standardized Activities (PAQLQ(S)) by Juniper is a reliable measure of the influence of asthma on QL in children. The Polish Version of the questionnaire is a strict translation of the english one, however it is not completely validated, which in practice can evince in difficulties in understanding the meaning of the applied questions, probably because of the difference in the habits of both populations.
The aim of the study is valuation of quality of life (QL) in children with asthma and analysis of the factors that can have influence on it. The clinical problems included into the aim are to evaluate:
- the correlation between the QL and asthma control
- the utility of the Polish Version of PAQLQ(S) by Juniper, especially the understanding of each question and it's answers The results of this study can be very helpful in the future in developing a questionnaires to use in Polish Primary Care, according to which we would be able to see whether the asthma in our patients is being well controlled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Polish Version of PAQLQ(S) by Juniper, Other: spirometryChildren with asthma, both genders, from 7-18 years old. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with asthma.
Key inclusion criteria (3 listed)
- Clinical diagnosis of Asthma
- Asthma treatment at least 6 months before enrollment
- Must be able to do spirometry
Key exclusion criteria (2 listed)
- Children during the introductory period of the specific immunotherapy
- Other protracted diseases
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 |
|---|---|---|
| Polish Version of PAQLQ(S) by JuniperPolish Version of PAQLQ(S) by Juniper | Other | 1 |
| spirometryspirometry | Other | 1 |
Primary outcome
Not reported in the source record.
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 13 Sep 2010.
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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.
Iwona Stelmach, MD, PhD, Prof study chair
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Daniela Gjurow, MD principal investigator
Department of Pediatrics and Allergy, 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 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 3 inclusion and 2 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 13 Sep 2010. 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.
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 13 Sep 2010.