The protective effect of azelastine/fluticasone propionate (Dymista) on exercise-induced asthma

The protective effect of azelastine/fluticasone propionate (Dymista) on exercise-induced airway obstruction - Protective effect of DYM on EIAO

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001120-18-NL

Enrollment

Registered

2018-12-11

Start date

2019-01-17

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise-induced airway obstruction Asthma Allergic rhinitis

Interventions

Trade Name: Dymista (azelastine hydrochloride/fluticasone propionate) Product Name: Azelastine hydrochloride and fluticasone propionate Product Code: RVG 114215

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Clinical history of allergic rhinitis and EIB (exercise-induced bronchoconstriction) - Age between 12 and 18 years. - Ability to perform spirometry and FOT Are the trial subjects under 18? yes Number of subjects for this age range: 64 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Other pulmonary or cardiac illnesses - Severe EIB i.e. a fall of =40% FEV1 in the first ECT, requiring an acute change in maintenance medication (standard care) - Use of long acting bronchodilator agents 24 hours before testing - Use of short acting bronchodilator agents 8 hours before testing - Hospitalization due to asthma exacerbation in the last 4 weeks - Use of intranasal or systemic corticosteroids in the last 4 weeks prior to the study. - Use of antihistamines, cromoglycates, anticholinergics in two weeks prior the study or during the study. - Other changes in asthma medication during treatment period - Insufficient knowledge of the Dutch language

Design outcomes

Primary

Measure	Time frame
Main Objective: To analyze the protective effect of azelastine/fluticasone propionate against exercise-induced airway narrowing by measuring inspiratory and expiratory airflow limitation and airway resistance and reactance in asthmatic children. ;Timepoint(s) of evaluation of this end point: At day 1 and after 3 weeks; Secondary Objective: -Analyze the reduction in exercise-induced increase of airway resistance at low frequency, measured with FOT, after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the reduction in exercise-induced decrease of airway reactance at low frequency, measured with FOT, after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the increase in quality of life, measured with the pediatric asthma quality of life questionnaire (PAQLQ), after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the increase in control of asthma, measured with the asthma control test (ACT), after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo ; Primary end point(s): -The reduction in exercise-induced fall in FEV1 after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -The reduction in exercise-induced fall in MIF50 after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo.	—

Measure

Time frame

Main Objective: To analyze the protective effect of azelastine/fluticasone propionate against exercise-induced airway narrowing by measuring inspiratory and expiratory airflow limitation and airway resistance and reactance in asthmatic children. ;Timepoint(s) of evaluation of this end point: At day 1 and after 3 weeks; Secondary Objective: -Analyze the reduction in exercise-induced increase of airway resistance at low frequency, measured with FOT, after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the reduction in exercise-induced decrease of airway reactance at low frequency, measured with FOT, after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the increase in quality of life, measured with the pediatric asthma quality of life questionnaire (PAQLQ), after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the increase in control of asthma, measured with the asthma control test (ACT), after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo ; Primary end point(s): -The reduction in exercise-induced fall in FEV1 after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -The reduction in exercise-induced fall in MIF50 after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo.

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Secondary

Measure	Time frame
Secondary end point(s): -Analyze the reduction in exercise-induced increase of airway resistance at low frequency, measured with FOT, after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the reduction in exercise-induced decrease of airway reactance at low frequency, measured with FOT, after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the increase in quality of life, measured with the pediatric asthma quality of life questionnaire (PAQLQ), after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the increase in control of asthma, measured with the asthma control test (ACT), after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo ;Timepoint(s) of evaluation of this end point: At day 1 and after 3 weeks	—

Measure

Time frame

Secondary end point(s): -Analyze the reduction in exercise-induced increase of airway resistance at low frequency, measured with FOT, after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the reduction in exercise-induced decrease of airway reactance at low frequency, measured with FOT, after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the increase in quality of life, measured with the pediatric asthma quality of life questionnaire (PAQLQ), after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the increase in control of asthma, measured with the asthma control test (ACT), after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo ;Timepoint(s) of evaluation of this end point: At day 1 and after 3 weeks

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Countries

Netherlands

Contacts

Public ContactBoony Thio

Stichting Pediatrisch Onderzoek Enschede

b.thio@mst.nl0031544872310

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026