AsthmaPhase 4NCT00490243
Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma
A Phase 4 study testing budesonide and montelukast, budesonide and formoterol and montelukast in people with Asthma, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The present study was conducted to determine the effects of four week treatment with budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in children with atopic asthma on lung function: forced expiratory volume in one second, mid-expiratory flow, peak expiratory flow rate, resistance by… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- budesonide and montelukast, budesonide and formoterol and montelukast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2003to Oct 2006
- Phase
- Phase 4
- 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
Who may be able to join
- Male and female outpatients
- Aged 6 to 18 with a clinical diagnosis of bronchial asthma with a duration of at least 6 months before the first visit and with current history of moderate persistent asthma
- Sensitive to house dust mites as shown by positive skin-prick tests to Dermatophagoides pteronyssinus or Dermatophagoides farinae
- To become eligible for the active treatment period, patients and their parents were required to do reproducible spirometry, whole body plethysmography and interrupter technique.
- In order to be included in the study the patients had to have a resting FEV1 of more or equal 70%.
Who cannot join
- Study exclusions included:
- Active upper respiratory tract infection within 3 weeks before the study and acute sinus disease requiring antibiotic treatment within 1 month before the study
- Previous intubation
- Asthma hospitalisation during the 3 months before the first visit.
- Additional criteria were other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or psychiatric diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator.
- Excluded medications were β-blockers (eye drops included), astemizole within 3 months, or oral corticosteroids within 1 month before the first visit.
- Patients who were receiving immunotherapy were also excluded.
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
Official title: A Randomized, Double-Blind Trial of the Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma
The present study was conducted to determine the effects of four week treatment with budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in children with atopic asthma on lung function: forced expiratory volume in one second, mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique, plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and clinical symptoms.
Read the detailed description
Asthma is one of the most common chronic disease worldwide, imposing a substantial social burden on children. Allergic inflammation is responsible for all clinical symptoms of asthma. The effects of allergic inflammation are: bronchial muscle constriction, excessive mucus production, and edema of mucosa, all elements of "asthmatic triad" causing bronchial obturation. Normal lung function is one of the goals of asthma management. In most of the studies the effect of monotherapy on the symptom scores, lung function parameters and bronchial hyperreactivity was assessed.
The present study was conducted to determine the effects of four week treatment with budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in children with atopic asthma on lung function: forced expiratory volume in one second, mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique, plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and clinical symptoms.
- Conditions
- Asthma
- Being tested
- budesonide and montelukast, budesonide and formoterol, montelukast, budesonide, placebo
- Keywords
- Asthma, Children, Exercise, Pulmonary Function, Budesonide, Montelukast, Formoterol
- Medical subject headings
- Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonide and montelukastDrug
budesonide and formoterolDrug
montelukastDrug
budesonideDrug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
FEF25-75%, Rint, sRaw, FEV1, PEFR, maximum percentage fall in FEV1 after exercise test, the area under the curve (AUC) for the FEV1 values over the 20-min period from exercise
Measured: baseline (second visit) and after 4 weeks of treatment (third visit)
Secondary outcomes (1)
symptoms score
Measured: baseline (second visit) and after 4 weeks of treatment (third visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startJul 2003
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Investigators
- Tomasz Grzelewski, MD, PhD, Principal investigator, Department of Pediatrics and Allergy, Medical University of Lodz, PolandIwona Stelmach, MD, PhD, Prof, Study chair, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490243
- Sponsor's protocol ID
- RNN/135/03/KE
- Status last verified
- Jun 2007
- First submitted
- 21 Jun 2007
- Last updated
- 28 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stelmach I, Grzelewski T, Bobrowska-Korzeniowska M, Stelmach P, Kuna P. A randomized, double-blind trial of the effect of anti-asthma treatment on lung function in children with asthma. Pulm Pharmacol Ther. 2007;20(6):691-700. doi: 10.1016/j.pupt.2006.08.003. Epub 2006 Sep 14.
PubMed 17046300
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Trial of the Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma
- ClinicalTrials.gov ID
- NCT00490243
- Acronym / sponsor ID
- RNN/135/03/KE
- Conditions
- Asthma
- Keywords
- Asthma, Children, Exercise, Pulmonary Function, Budesonide, Montelukast, Formoterol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Jul 2003
- Study completion
- Oct 2006 (actual)
- First posted
- 22 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 present study was conducted to determine the effects of four week treatment with budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in children with atopic asthma on lung function: forced expiratory volume in one second, mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique, plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and clinical symptoms.
Detailed description
Asthma is one of the most common chronic disease worldwide, imposing a substantial social burden on children. Allergic inflammation is responsible for all clinical symptoms of asthma. The effects of allergic inflammation are: bronchial muscle constriction, excessive mucus production, and edema of mucosa, all elements of "asthmatic triad" causing bronchial obturation. Normal lung function is one of the goals of asthma management. In most of the studies the effect of monotherapy on the symptom scores, lung function parameters and bronchial hyperreactivity was assessed.
The present study was conducted to determine the effects of four week treatment with budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in children with atopic asthma on lung function: forced expiratory volume in one second, mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique, plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and clinical symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male and female outpatients
- Aged 6 to 18 with a clinical diagnosis of bronchial asthma with a duration of at least 6 months before the first visit and with current history of moderate persistent asthma
- Sensitive to house dust mites as shown by positive skin-prick tests to Dermatophagoides pteronyssinus or Dermatophagoides farinae
- To become eligible for the active treatment period, patients and their parents were required to do reproducible spirometry, whole body plethysmography and interrupter technique.
- In order to be included in the study the patients had to have a resting FEV1 of more or equal 70%.
Key exclusion criteria (7 listed)
- Active upper respiratory tract infection within 3 weeks before the study and acute sinus disease requiring antibiotic treatment within 1 month before the study
- Previous intubation
- Asthma hospitalisation during the 3 months before the first visit.
- Additional criteria were other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or psychiatric diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator.
- Excluded medications were β-blockers (eye drops included), astemizole within 3 months, or oral corticosteroids within 1 month before the first visit.
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 |
|---|---|---|
| budesonide and montelukast | Drug | – |
| budesonide and formoterol | Drug | – |
| montelukast | Drug | – |
| budesonide | Drug | – |
| placebo | Drug | – |
Primary outcome
FEF25-75%, Rint, sRaw, FEV1, PEFR, maximum percentage fall in FEV1 after exercise test, the area under the curve (AUC) for the FEV1 values over the 20-min period from exercise
Time frame: baseline (second visit) and after 4 weeks of treatment (third visit)
1 secondary outcome
symptoms score
Time frame: baseline (second visit) and after 4 weeks of treatment (third visit)
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 28 Jun 2007.
- Results publication: PubMed 17046300Stelmach I, Grzelewski T, Bobrowska-Korzeniowska M, Stelmach P, Kuna P. A randomized, double-blind trial of the effect of anti-asthma treatment on lung function in children with asthma. Pulm Pharmacol Ther. 2007;20(6):691-700. doi: 10.1016/j.pupt.2006.08.003. Epub 2006 Sep 14.
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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.
Tomasz Grzelewski, MD, PhD principal investigator
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Iwona Stelmach, MD, PhD, Prof study chair
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?
A Phase 4 study testing budesonide and montelukast, budesonide and formoterol and montelukast in people with 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 5 inclusion and 7 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 28 Jun 2007. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
FEF25-75%, Rint, sRaw, FEV1, PEFR, maximum percentage fall in FEV1 after exercise test, the area under the curve (AUC) for the FEV1 values over the 20-min period from exercise (time frame: baseline (second visit) and after 4 weeks of treatment (third visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00490243, which also lists 1 linked publication.
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 28 Jun 2007.