Airway ReactivityPhase 4NCT02494466
Preoperative Use of Montelukast Sodium
A Phase 4 study testing montelukast sodium in people with Airway Reactivity, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Supraglottic airway equipment used during anaesthesia application can lead to airway reactivity or even larynx spasm in sensitive children. Montelukast Sodium, used in asthma treatment, is a cysteinyl leukotriene Type 1 antagonist which reduces leukotriene C4, leukotriene D4 and leukotriene E4 synthesis. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Reactivity
- What is being tested?
- montelukast sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2014to Jun 2015
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients undergoing inguinal hernia surgery
Who cannot join
- If receiving asthma treatment,
- If they had URTI in the last week and
- If LMA could not be placed at a single attempt.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects on Airway Reactivity of the Use of Preoperative Montelukast Sodium
Supraglottic airway equipment used during anaesthesia application can lead to airway reactivity or even larynx spasm in sensitive children.
Montelukast Sodium, used in asthma treatment, is a cysteinyl leukotriene Type 1 antagonist which reduces leukotriene C4, leukotriene D4 and leukotriene E4 synthesis. The use of Montelukast Sodium in airway reactivity is known to reduce the need for bronchodilator and corticosteroids.
Read the detailed description
The study will comprise 30 american society of anesthesiology (ASA) I-III patients, aged 4-8 years, undergoing inguinal hernia surgery. Patients will exclude if receiving asthma treatment, if they had upper respiratory tract infection in the last week and if the laryngeal mask airway (LMA) could not be placed at a single attempt.
Patients will be separated into 3 groups as Group E (n=10) with high immunoglobulin E (IgE), Group C (n=10) with normal IgE and Group M (n=10) who were administered with 4mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.
With spontaneous breathing after anaesthesia induction, a classic LMA will be placed. Anaesthesia will be maintained with a mixture of 1.3 minimum alveolar concentration (MAC) sevoflurane 500%2 - N2O. At 5-minute intervals, oxygen saturation (sPO2), End-Tidal carbon dioxide, Heart Rate, tidal volume (VT), respiratory rate (f) and peak airway pressure (PAP) will be monitored and coughing, apnea, laryngospasm , bronchospasm, desaturation and need for steroids will be noted.
- Conditions
- Airway Reactivity
- Being tested
- montelukast sodium
- Keywords
- Airway Resistance, montelukast sodium, laryngeal mask airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukast sodiumDrug
4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.
| Study group | Role | What they receive |
|---|---|---|
| Group E (n=10) | Active comparator | Patients with high Ig E levels Receives: Drug: montelukast sodium |
| Group C (n=10) | Active comparator | Patients with normal Ig E levels Receives: Drug: montelukast sodium |
| Group M (n=10) | Active comparator | Patients who would be administered with 4mg PO MS 10 days before surgery because of high IgE Receives: Drug: montelukast sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with bronchospasm as a Measure of airway reactivity
Measured: during the operation
Number of Participants with laryngospasm as a Measure of airway reactivity
Measured: during the operation
Number of Participants with apnea
Measured: during the operation
Secondary outcomes (2)
amount of applied steroids
steroids can prevent airway reactivity symptoms
Measured: during the operation
peak airway pressures as a measurement of airway reactivity
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startMay 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Airway ReactivityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gulsah Karaoren, Umraniye Education and Research Hospital
- Investigators
- Nurten Bakan, MD, Study chair, Unraniye training and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494466
- Sponsor's protocol ID
- GK6
- Status last verified
- Jul 2015
- First submitted
- 5 May 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Casares-Alonso I, Cano-Garcinuno A, Blanco-Quiros A, Perez-Garcia I. Anti-asthmatic prescription variability in children according to age. Allergol Immunopathol (Madr). 2015 Jul-Aug;43(4):383-91. doi: 10.1016/j.aller.2014.05.010. Epub 2014 Oct 23.
PubMed 25444114Bush A. Montelukast in paediatric asthma: where we are now and what still needs to be done? Paediatr Respir Rev. 2015 Mar;16(2):97-100. doi: 10.1016/j.prrv.2014.10.007. Epub 2014 Dec 12.
PubMed 25499571
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Airway Reactivity of the Use of Preoperative Montelukast Sodium
- ClinicalTrials.gov ID
- NCT02494466
- Acronym / sponsor ID
- GK6
- Conditions
- Airway Reactivity
- Keywords
- Airway Resistance, montelukast sodium, laryngeal mask airway
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- May 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jul 2015 (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.
Supraglottic airway equipment used during anaesthesia application can lead to airway reactivity or even larynx spasm in sensitive children.
Montelukast Sodium, used in asthma treatment, is a cysteinyl leukotriene Type 1 antagonist which reduces leukotriene C4, leukotriene D4 and leukotriene E4 synthesis. The use of Montelukast Sodium in airway reactivity is known to reduce the need for bronchodilator and corticosteroids.
Detailed description
The study will comprise 30 american society of anesthesiology (ASA) I-III patients, aged 4-8 years, undergoing inguinal hernia surgery. Patients will exclude if receiving asthma treatment, if they had upper respiratory tract infection in the last week and if the laryngeal mask airway (LMA) could not be placed at a single attempt.
Patients will be separated into 3 groups as Group E (n=10) with high immunoglobulin E (IgE), Group C (n=10) with normal IgE and Group M (n=10) who were administered with 4mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.
With spontaneous breathing after anaesthesia induction, a classic LMA will be placed. Anaesthesia will be maintained with a mixture of 1.3 minimum alveolar concentration (MAC) sevoflurane 500%2 - N2O. At 5-minute intervals, oxygen saturation (sPO2), End-Tidal carbon dioxide, Heart Rate, tidal volume (VT), respiratory rate (f) and peak airway pressure (PAP) will be monitored and coughing, apnea, laryngospasm , bronchospasm, desaturation and need for steroids will be noted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group E (n=10) | Active comparator | Drug: montelukast sodiumPatients with high Ig E levels |
| Group C (n=10) | Active comparator | Drug: montelukast sodiumPatients with normal Ig E levels |
| Group M (n=10) | Active comparator | Drug: montelukast sodiumPatients who would be administered with 4mg PO MS 10 days before surgery because of high IgE |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients undergoing inguinal hernia surgery
Key exclusion criteria (3 listed)
- If receiving asthma treatment,
- If they had URTI in the last week and
- If LMA could not be placed at a single attempt.
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 |
|---|---|---|
| montelukast sodium4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE. | Drug | Group C (n=10), Group E (n=10), Group M (n=10) |
Primary outcome
Number of Participants with bronchospasm as a Measure of airway reactivity
Time frame: during the operation
Number of Participants with laryngospasm as a Measure of airway reactivity
Time frame: during the operation
Number of Participants with apnea
Time frame: during the operation
2 secondary outcomes
amount of applied steroids
Time frame: during the operation
peak airway pressures as a measurement of airway reactivity
Time frame: during the operation
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 10 Jul 2015.
- Background: PubMed 25444114Casares-Alonso I, Cano-Garcinuno A, Blanco-Quiros A, Perez-Garcia I. Anti-asthmatic prescription variability in children according to age. Allergol Immunopathol (Madr). 2015 Jul-Aug;43(4):383-91. doi: 10.1016/j.aller.2014.05.010. Epub 2014 Oct 23.
- Results publication: PubMed 25499571Bush A. Montelukast in paediatric asthma: where we are now and what still needs to be done? Paediatr Respir Rev. 2015 Mar;16(2):97-100. doi: 10.1016/j.prrv.2014.10.007. Epub 2014 Dec 12.
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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.
Nurten Bakan, MD study chair
Unraniye training and research hospital
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 sodium in people with Airway Reactivity, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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 10 Jul 2015. 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 Turkey (Türkiye). 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?
Number of Participants with bronchospasm as a Measure of airway reactivity (time frame: during the operation). The study lists 3 primary outcomes in all. 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 NCT02494466, which also lists 2 linked publications.
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 10 Jul 2015.