Asthma in ChildrenPhase 3NCT03372473
Montelukast and Loratadine in Children With Asthma
A Phase 3 study testing Montelukast mixed with Loratadine and Montelukast in people with Asthma in Children, run by Innovacion y Desarrollo de Estrategias en Salud.
Trial summary
Randomized controlled trial in 80 children with mild to persistent moderate asthma, who were randomized to receive montelukast 5mg + loratadine 5mg vs. montelukast 5mg + placebo for loratadine to evaluate the efficacy in terms of improvement of symptoms. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Montelukast mixed with Loratadine and Montelukast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2016to 30 Jun 2017
- Phase
- Phase 3
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 6 to 12 years old
- Any sex
- Persistent mild to moderate asthma
- Signature of informed consent letter by parents or guardians
- Letter of assent of the minor for children over 9 years of age
Who cannot join
- Chronic pathologies associated with the disease of interest (heart disease, nephropathy, liver disease of any kind)
- Any other lung disease other than asthma
- History of hypersensitivity to montelukast or loratadine
- Concomitant use of medications that interact significantly with montelukast or loratadine
About this study
Official title: Safety and Efficacy of Montelukast + Loratadine vs. Montelukast for the Control of Mild to Moderate Persistent Asthma in Children: Randomized Controlled Clinical Trial
Randomized controlled trial in 80 children with mild to persistent moderate asthma, who were randomized to receive montelukast 5mg + loratadine 5mg vs. montelukast 5mg + placebo for loratadine to evaluate the efficacy in terms of improvement of symptoms. Secondary outcome was the days off without the use of rescue medication; reduction of levels of cysteinyl leukotrienes (Cys-LTS), nitric oxide (FeNO), intracellular adhesion molecule type 1 (ICAM-1) and interleukin 8 (IL-8) in condensed exhaled air; the improvement of day and night symptoms; the reduction in the frequency of night awakenings; the improvement in the quality of life; the percentage of related adverse events; the need to use systemic steroids; the number of visits to the emergency department secondary to the presence of an asthma attack; the number of hospitalizations secondary to asthma attacks; and the improvement in the percentage of FEV1 in relation to the predicted.
Read the detailed description
Asthma is a disease with increasing prevalence worldwide that produces significant deterioration of the quality of life in children and development of important complications and economic, social impact. Considering the concept of a common airway (coexistence of asthma and rhinitis), joint management initiatives with anti-asthmatics and anti-histamines have been published. The primary objective of this clinical trial is to evaluate the efficacy and safety of the use of montelukast + loratadine in children with asthma on the improvement of symptoms and secondarily to evaluate the impact on a) the days off without the use of rescue medication; b) reduction of levels of cysteinyl leukotrienes (Cys-LTS), nitric oxide (FeNO), intracellular adhesion molecule type 1 (ICAM-1) and interleukin 8 (IL-8) in condensed exhaled air; c) the improvement of day and night symptoms; d) the reduction in the frequency of night awakenings; e) the improvement in the quality of life; f) the percentage of related adverse events; g) the need to use systemic steroids; h) the number of visits to the emergency department secondary to the presence of an asthma attack; i) the number of hospitalizations secondary to asthma attacks; and j) the improvement in the percentage of FEV1 in relation to the predicted. We included 80 children from 6 to 12 years old, any sex, with mild to moderate persistent asthma, after signing an informed consent letter by parents or guardians or signing the child's consent (> 8 years). Children with chronic diseases associated with the disease of interest were excluded (heart disease, nephropathy, liver disease of any kind); with any other lung disease other than asthma; with a history of hypersensitivity to montelukast or loratadine or with a history of concomitant use of medications that interact significantly with montelukast or loratadine
- Conditions
- Asthma in Children
- Being tested
- Montelukast mixed with Loratadine, Montelukast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast mixed with LoratadineDrug
Montelukast 5mg mixed with Loratadine 5mg, one dose per day
MontelukastDrug
Montelukast 5mg
| Study group | Role | What they receive |
|---|---|---|
| Montelukast mixed with Loratadine | Experimental | Montelukast 5mg mixed with Loratadine 5mg one dose a day Receives: Drug: Montelukast mixed with Loratadine |
| Montelukast | Active comparator | Montelukast 5mg one dose per day Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free of symptoms
Number of days free of symptoms associated to asthma episodes
Measured: 10 weeks
Secondary outcomes (6)
Free of rescue medication
Number of days free for use of rescue medications
Measured: 10 weeks
Reduction of airway inflammatory profile
Measurement of inflamatory biomarkers in exhaled respiratory air
Measured: 10 weeks
Reduction of awakenings
Frequency of nocturn awakenings
Measured: 10 weeks
Quality of Life
Changes in PedsQL during the treatment
Measured: 10 weeks
Emergency visits
Number of emergency visits secondary to asthma crisis
Measured: 10 weeks
Adverse Events
Frequency of reported adverse events
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start10 Jan 2016
- Primary completion1 Feb 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized clinical crossover trial, in 80 children who were allocated to receive montelukast + loratadine vs montelukast in two different periods of 4 weeks each, with a 2 weeks of wash-out between periods of treatment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovacion y Desarrollo de Estrategias en Salud
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Pediatrics, Mexico, Laboratorios Senosiain, S.A. de C.V.
- Responsible party
- Principal investigator, Pedro Gutierrez Castrellon, Innovacion y Desarrollo de Estrategias en Salud
- Investigators
- Pedro Gutierrez Castrellon, MD, Principal investigator, Hospital General Dr. Manuel Gea Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372473
- Sponsor's protocol ID
- Montelukast2017
- Status last verified
- Dec 2017
- First submitted
- 8 Dec 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
PubMed 15817806Carpagnano GE, Spanevello A, Sabato R, Depalo A, Palladino GP, Bergantino L, Foschino Barbaro MP. Systemic and airway inflammation in sleep apnea and obesity: the role of ICAM-1 and IL-8. Transl Res. 2010 Jan;155(1):35-43. doi: 10.1016/j.trsl.2009.09.004.
PubMed 20004360Carraro S, Corradi M, Zanconato S, Alinovi R, Pasquale MF, Zacchello F, Baraldi E. Exhaled breath condensate cysteinyl leukotrienes are increased in children with exercise-induced bronchoconstriction. J Allergy Clin Immunol. 2005 Apr;115(4):764-70. doi: 10.1016/j.jaci.2004.10.043.
PubMed 15805996Zanconato S, Carraro S, Corradi M, Alinovi R, Pasquale MF, Piacentini G, Zacchello F, Baraldi E. Leukotrienes and 8-isoprostane in exhaled breath condensate of children with stable and unstable asthma. J Allergy Clin Immunol. 2004 Feb;113(2):257-63. doi: 10.1016/j.jaci.2003.10.046.
PubMed 14767439Massingham K, Fox S, Smaldone A. Asthma therapy in pediatric patients: a systematic review of treatment with montelukast versus inhaled corticosteroids. J Pediatr Health Care. 2014 Jan-Feb;28(1):51-62. doi: 10.1016/j.pedhc.2012.11.005. Epub 2013 Jan 9.
PubMed 23312367Corren J, Manning BE, Thompson SF, Hennessy S, Strom BL. Rhinitis therapy and the prevention of hospital care for asthma: a case-control study. J Allergy Clin Immunol. 2004 Mar;113(3):415-9. doi: 10.1016/j.jaci.2003.11.034.
PubMed 15007339
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Montelukast + Loratadine vs. Montelukast for the Control of Mild to Moderate Persistent Asthma in Children: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03372473
- Acronym / sponsor ID
- Montelukast2017
- Conditions
- Asthma in Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Innovacion y Desarrollo de Estrategias en SaludUniversity, hospital or other
- Collaborators
- National Institute of Pediatrics, Mexico, Laboratorios Senosiain, S.A. de C.V.
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 13 Dec 2017 (actual)
- 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.
Randomized controlled trial in 80 children with mild to persistent moderate asthma, who were randomized to receive montelukast 5mg + loratadine 5mg vs. montelukast 5mg + placebo for loratadine to evaluate the efficacy in terms of improvement of symptoms. Secondary outcome was the days off without the use of rescue medication; reduction of levels of cysteinyl leukotrienes (Cys-LTS), nitric oxide (FeNO), intracellular adhesion molecule type 1 (ICAM-1) and interleukin 8 (IL-8) in condensed exhaled air; the improvement of day and night symptoms; the reduction in the frequency of night awakenings; the improvement in the quality of life; the percentage of related adverse events; the need to use systemic steroids; the number of visits to the emergency department secondary to the presence of an asthma attack; the number of hospitalizations secondary to asthma attacks; and the improvement in the percentage of FEV1 in relation to the predicted.
Detailed description
Asthma is a disease with increasing prevalence worldwide that produces significant deterioration of the quality of life in children and development of important complications and economic, social impact. Considering the concept of a common airway (coexistence of asthma and rhinitis), joint management initiatives with anti-asthmatics and anti-histamines have been published. The primary objective of this clinical trial is to evaluate the efficacy and safety of the use of montelukast + loratadine in children with asthma on the improvement of symptoms and secondarily to evaluate the impact on a) the days off without the use of rescue medication; b) reduction of levels of cysteinyl leukotrienes (Cys-LTS), nitric oxide (FeNO), intracellular adhesion molecule type 1 (ICAM-1) and interleukin 8 (IL-8) in condensed exhaled air; c) the improvement of day and night symptoms; d) the reduction in the frequency of night awakenings; e) the improvement in the quality of life; f) the percentage of related adverse events; g) the need to use systemic steroids; h) the number of visits to the emergency department secondary to the presence of an asthma attack; i) the number of hospitalizations secondary to asthma attacks; and j) the improvement in the percentage of FEV1 in relation to the predicted. We included 80 children from 6 to 12 years old, any sex, with mild to moderate persistent asthma, after signing an informed consent letter by parents or guardians or signing the child's consent (> 8 years). Children with chronic diseases associated with the disease of interest were excluded (heart disease, nephropathy, liver disease of any kind); with any other lung disease other than asthma; with a history of hypersensitivity to montelukast or loratadine or with a history of concomitant use of medications that interact significantly with montelukast or loratadine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical crossover trial, in 80 children who were allocated to receive montelukast + loratadine vs montelukast in two different periods of 4 weeks each, with a 2 weeks of wash-out between periods of treatment
| Arm | Type | Receives |
|---|---|---|
| Montelukast mixed with Loratadine | Experimental | Drug: Montelukast mixed with LoratadineMontelukast 5mg mixed with Loratadine 5mg one dose a day |
| Montelukast | Active comparator | Drug: MontelukastMontelukast 5mg one dose per day |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age from 6 to 12 years old
- Any sex
- Persistent mild to moderate asthma
- Signature of informed consent letter by parents or guardians
- Letter of assent of the minor for children over 9 years of age
Key exclusion criteria (4 listed)
- Chronic pathologies associated with the disease of interest (heart disease, nephropathy, liver disease of any kind)
- Any other lung disease other than asthma
- History of hypersensitivity to montelukast or loratadine
- Concomitant use of medications that interact significantly with montelukast or loratadine
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 mixed with LoratadineMontelukast 5mg mixed with Loratadine 5mg, one dose per day | Drug | Montelukast mixed with Loratadine |
| MontelukastMontelukast 5mg | Drug | Montelukast |
Primary outcome
Free of symptoms
Time frame: 10 weeks
Number of days free of symptoms associated to asthma episodes
6 secondary outcomes
Free of rescue medication
Time frame: 10 weeks
Reduction of airway inflammatory profile
Time frame: 10 weeks
Reduction of awakenings
Time frame: 10 weeks
Quality of Life
Time frame: 10 weeks
Emergency visits
Time frame: 10 weeks
Adverse Events
Time frame: 10 weeks
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 Dec 2017.
- Results publication: PubMed 15817806American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
- Results publication: PubMed 20004360Carpagnano GE, Spanevello A, Sabato R, Depalo A, Palladino GP, Bergantino L, Foschino Barbaro MP. Systemic and airway inflammation in sleep apnea and obesity: the role of ICAM-1 and IL-8. Transl Res. 2010 Jan;155(1):35-43. doi: 10.1016/j.trsl.2009.09.004.
- Results publication: PubMed 15805996Carraro S, Corradi M, Zanconato S, Alinovi R, Pasquale MF, Zacchello F, Baraldi E. Exhaled breath condensate cysteinyl leukotrienes are increased in children with exercise-induced bronchoconstriction. J Allergy Clin Immunol. 2005 Apr;115(4):764-70. doi: 10.1016/j.jaci.2004.10.043.
- Results publication: PubMed 14767439Zanconato S, Carraro S, Corradi M, Alinovi R, Pasquale MF, Piacentini G, Zacchello F, Baraldi E. Leukotrienes and 8-isoprostane in exhaled breath condensate of children with stable and unstable asthma. J Allergy Clin Immunol. 2004 Feb;113(2):257-63. doi: 10.1016/j.jaci.2003.10.046.
- Results publication: PubMed 23312367Massingham K, Fox S, Smaldone A. Asthma therapy in pediatric patients: a systematic review of treatment with montelukast versus inhaled corticosteroids. J Pediatr Health Care. 2014 Jan-Feb;28(1):51-62. doi: 10.1016/j.pedhc.2012.11.005. Epub 2013 Jan 9.
- Results publication: PubMed 15007339Corren J, Manning BE, Thompson SF, Hennessy S, Strom BL. Rhinitis therapy and the prevention of hospital care for asthma: a case-control study. J Allergy Clin Immunol. 2004 Mar;113(3):415-9. doi: 10.1016/j.jaci.2003.11.034.
- Individual participant dataSharing planned: No
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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.
Pedro Gutierrez Castrellon, MD principal investigator
Hospital General Dr. Manuel Gea Gonzalez
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Montelukast mixed with Loratadine and Montelukast in people with Asthma in Children, run by Innovacion y Desarrollo de Estrategias en Salud.
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 4 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 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Free of symptoms (time frame: 10 weeks). 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 NCT03372473, which also lists 6 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 13 Dec 2017.