Allergic AsthmaNCT00515775
Influence of a Inhaled Corticosteroid Therapy Versus Corticosteroid + LABA Therapy on the FeNO of Asthmatic Children
An observational study of Allergic Asthma, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The purpose of the study is to investigate, whether the FeNO concentration of asthmatic children is influenced differently by inhaled corticosteroid compared to inhaled corticosteroid + long acting beta agonist. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Allergic Asthma
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2005to Oct 2008
- 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: Allergic asthmatics
Who may be able to join
- allergic asthma since > 6 months equal or lower corticosteroid therapy before study entry FEV1>50%
Who cannot join
- severe asthma respiratory infection within the last 4 weeks smoking
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Children´s Hospital, Technical University of Dresden
Dresden, 01307
About this study
The purpose of the study is to investigate, whether the FeNO concentration of asthmatic children is influenced differently by inhaled corticosteroid compared to inhaled corticosteroid + long acting beta agonist. The study hypothesis is that the FeNO concentration is more decreased in patients with a combination therapy compared to those with a corticosteroid mono therapy.
- Conditions
- Allergic Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startSep 2005
- Primary completionJun 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Christian Vogelberg, MD, Principal investigator, University Children´s Hospital, Technical University of Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515775
- Sponsor's protocol ID
- D5890L00015
- Status last verified
- Oct 2008
- First submitted
- 13 Aug 2007
- Last updated
- 13 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Inhaled Corticosteroid Therapy Versus Corticosteroid + LABA Therapy on the FeNO of Asthmatic Children
- ClinicalTrials.gov ID
- NCT00515775
- Acronym / sponsor ID
- D5890L00015
- Conditions
- Allergic Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 14 Aug 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 purpose of the study is to investigate, whether the FeNO concentration of asthmatic children is influenced differently by inhaled corticosteroid compared to inhaled corticosteroid + long acting beta agonist. The study hypothesis is that the FeNO concentration is more decreased in patients with a combination therapy compared to those with a corticosteroid mono therapy.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Allergic asthmatics
Key inclusion criteria (1 listed)
- allergic asthma since > 6 months equal or lower corticosteroid therapy before study entry FEV1>50%
Key exclusion criteria (1 listed)
- severe asthma respiratory infection within the last 4 weeks smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 Feb 2009.
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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.
Christian Vogelberg, MD principal investigator
University Children´s Hospital, Technical University of Dresden
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 Allergic Asthma, run by Technische Universität Dresden at 1 site in Germany.
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 13 Feb 2009. 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 Germany. 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 Feb 2009.