Exercise-Induced AsthmaPhase 4TEMPENCT00935415
Time-Effect of Montelukast Protection
A Phase 4 study testing Montelukast in people with Exercise-Induced Asthma and Asthma, run by Universita di Verona at 1 site in Italy.
Trial summary
The aim of this study is to verify MNT time of onset of protection against EIB in asthmatic children by evaluating different time intervals between dosing and challenge, after a single-dose and after three days of once a day MNT administration. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Exercise-Induced Asthma, Asthma
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2007to Aug 2008
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with exercise-induced asthma
Who cannot join
- viral infections
- montelukast treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time-Effect of Montelukast on Protection Against Exercise-Induced Bronchoconstriction
The aim of this study is to verify MNT time of onset of protection against EIB in asthmatic children by evaluating different time intervals between dosing and challenge, after a single-dose and after three days of once a day MNT administration.
Read the detailed description
Within few days after a baseline exercise challenge, children was randomized to a double blind, placebo-controlled, three day doses, crossover study design. In practice each eligible patient was randomized by a computer-generated schedule to receive in sequence double-blind treatments with placebo or MNT (5 mg). Patients in sequence 1 received MNT, then crossed over to matching placebo; vice versa the case was for patients in sequence 2. Placebo and active treatments were separated by a 7-10 day wash-out period. Each child was assigned to one out of seven groups in order to perform the exercise challenge at different time intervals from drug administration which occurred always at 8.00 A.M. On day one the challenge was performed in the different groups 1, 2, 3, 4, 5, 6, and 8 hours after drug administration, respectively. Then treatment was continued as a single day dose for three consecutive days and a third challenge was then performed at the same time of the day.
- Conditions
- Exercise-Induced Asthma, Asthma
- Being tested
- Montelukast, Placebo
- Keywords
- asthma, exercise-induced bronchoconstriction, montelukast, clinical protection, children, time effect
- Medical subject headings
- Asthma, Exercise-Induced, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called Singulair
Montelukast 5 mg
PlaceboDrug
capsules of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Active comparator | capsules prepared in blindness Receives: Drug: Montelukast |
| Placebo | Placebo comparator | matched placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal percentage fall in FEV1 after exercise test from the baseline value
Measured: at the first and at the third day of single day drug administration
Secondary outcomes (1)
clinical protection
Measured: at the first and at the third day of single day drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJan 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-Induced 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Investigators
- Attilio Boner, MD, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935415
- Sponsor's protocol ID
- PPDD1962
- Acronym
- TEMPE
- Status last verified
- Jul 2009
- First submitted
- 7 Jul 2009
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Effect of Montelukast on Protection Against Exercise-Induced Bronchoconstriction
- ClinicalTrials.gov ID
- NCT00935415
- Acronym / sponsor ID
- TEMPE / PPDD1962
- Conditions
- Exercise-Induced Asthma, Asthma
- Keywords
- asthma, exercise-induced bronchoconstriction, montelukast, clinical protection, children, time effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 9 Jul 2009 (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 this study is to verify MNT time of onset of protection against EIB in asthmatic children by evaluating different time intervals between dosing and challenge, after a single-dose and after three days of once a day MNT administration.
Detailed description
Within few days after a baseline exercise challenge, children was randomized to a double blind, placebo-controlled, three day doses, crossover study design. In practice each eligible patient was randomized by a computer-generated schedule to receive in sequence double-blind treatments with placebo or MNT (5 mg). Patients in sequence 1 received MNT, then crossed over to matching placebo; vice versa the case was for patients in sequence 2. Placebo and active treatments were separated by a 7-10 day wash-out period. Each child was assigned to one out of seven groups in order to perform the exercise challenge at different time intervals from drug administration which occurred always at 8.00 A.M. On day one the challenge was performed in the different groups 1, 2, 3, 4, 5, 6, and 8 hours after drug administration, respectively. Then treatment was continued as a single day dose for three consecutive days and a third challenge was then performed at the same time of the day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Active comparator | Drug: Montelukastcapsules prepared in blindness |
| Placebo | Placebo comparator | Drug: Placebomatched placebo |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children with exercise-induced asthma
Key exclusion criteria (2 listed)
- viral infections
- montelukast treatment
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 |
|---|---|---|
| MontelukastAlso: SingulairMontelukast 5 mg | Drug | Montelukast |
| Placebocapsules of matching placebo | Drug | Placebo |
Primary outcome
maximal percentage fall in FEV1 after exercise test from the baseline value
Time frame: at the first and at the third day of single day drug administration
1 secondary outcome
clinical protection
Time frame: at the first and at the third day of single day drug administration
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 9 Jul 2009.
Related trials for Exercise-Induced Asthma
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RecruitingObservational study
Swiss Paediatric Airway Cohort
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Recruiting
The Rainbow Study - the Effect of Feedback on Asthmatic Symptom Perception
Asthma in Children, Exercise Induced 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.
Attilio Boner, MD principal investigator
Universita di Verona
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 Montelukast in people with Exercise-Induced Asthma and Asthma, run by Universita di Verona at 1 site in Italy.
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 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 9 Jul 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 Italy. 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. Some participants in this study may receive a placebo. 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?
maximal percentage fall in FEV1 after exercise test from the baseline value (time frame: at the first and at the third day of single day drug administration). 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 9 Jul 2009.