Optimal Type of Inhaler in Cough Variant- or Cough Predominant Asthma

Study Overview
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Brief Summary
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Asthma management is based on inhaled therapy, mainly on inhaled glucocorticosteroids (ICS). The efficacy of inhaled therapy depends on type of inhaler and proper inhalation skills. Additionally, in cough variant- or cough predominant asthma aerosol or dry powder of inhaler may tease upper airway and induce cough. The aim of the study is to analyze if type of inhaler (DPI vs MDI) affects the efficacy of the management in cough variant or cough predominant asthma. Twenty two patients with cough variant- or cough predominant asthma will be enrolled into the study. Initially cough severity (in VAS scale), cough related quality of life (in Leicester Cough Questionnaire, LCQ) and number of cough episodes during 2 hours will be estimated. Additionally Asthma Control Test (ACT), Asthma Quality of Life Questionnaire (AQLQ) and spirometry will be performed. Then, budesonide or budesonide and formoterol will be used in Aerolizer / Breezhaler or pMDI in turn (each for 14 days) in the same doses. Inhalation technique will be checked and if needed corrected. After 14 days and then after 28 days, cough severity, LCQ, number of cough episodes, ACT, AQLQ, spirometry and inhalation technique will be assessed. The results will be based on differences in cough severity, cough related quality of life, asthma related quality of life, control of asthma and number of cough episodes between therapy with DPI and MDI.

Detailed Description
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Cough may be caused by both cough variant asthma or cough predominant asthma in 20-30% adults with chronic cough. Asthma management is based on inhaled therapy, mainly on inhaled glucocorticosteroids (ICS). The efficacy of inhaled therapy depends on type of inhaler and proper inhalation skills (1-2). Many of patients with asthma (as well as with COPD) make mistakes during inhaling, what negatively affect efficacy of management (3-4). Additionally, in cough variant- or cough predominant asthma aerosol or dry powder of inhaler may tease upper airway and induce cough (5). Therefore aim of the study is to analyze if type of inhaler (Dry Powder Inhaler, DPI vs pressurized Metered Dose Inhaler, MDI) affects the efficacy of the management in cough variant or cough predominant asthma. In all patients cough severity and tolerance of therapy will be analyzed during therapy with budesonide and/ or formoterol administered by DPI and MDI used in turn. Order of using different types of inhalers will be accidental. Twenty two patients with cough variant- or cough predominant asthma will be enrolled into the study. The sample size for the study was determined assuming that initially cough severity is at least 50/100 mm in VAS scale and minimal difference will be 20/100 mm. Providing these conditions, the sample size is 18 patients (α error 5%, power 80%); the sample was increased by 20% assuming drop out during the study. Initially cough severity (in 10 mm VAS scale), cough related quality of life (in Leicester Cough Questionnaire, LCQ) and number of cough episodes during 2 hours will be estimated. Additionally Asthma Control Test (ACT), Asthma Quality of Life Questionnaire (AQLQ) and spirometry will be performed. Then, budesonide or budesonide and formoterol will be stared in Aerolizer / Breezhaler or pMDI. Inhalation technique will be checked and if needed -corrected. After 14 days, cough severity, LCQ, number of cough episodes, ACT, AQLQ, spirometry and inhalation technique will be assessed. Then, type of inhaler will be changed, but the same doses of ICS and LABA will be administered. Once again inhalation technique will be checked and corrected if needed. After 28 days, cough severity, LCQ, number of cough episodes, ACT, AQLQ, spirometry and inhalation technique will be assessed again. The results will be based on differences in cough severity, cough related quality of life, asthma related quality of life, control of asthma and number of cough episodes between therapy with DPI and MDI.

Official Title
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Influence of Type of Inhaler on Cough Severity and Tolerance of Therapy in Patients With Cough Variant or Cough Predominant Asthma

Conditions
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Asthma, Cough Variant Asthma

Intervention / Treatment
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* Device: Budesonid or budesonide/fomoterol administered by DPI
* Device: Budesonid or budesonide/fomoterol administered by MDI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent for participating in the study Age ≥18 years Cough variant asthma or cough predominant asthma diagnosed and treated with inhaled corticosteroids (ICS) regularly at least 8 weeks prior to enrollment Exclusion Criteria: Lack of informed consent Age <18 years Diagnosis of cough variant- or cough predominant asthma shorter than 8 weeks before enrollment Symptoms of infection or asthma exacerbation 4 weeks prior to beginning of the study or during the study Comorbidity that could prevent patient from using DPI or MDI (i e. advanced vision disorders, some mental diseases, advanced neurological diseases).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: In all patients cough severity and tolerance of therapy will be analyzed during therapy with budesonide and/ or formoterol administered by DPI and MDI used in turn. Order of using different types of inhalers will be accidental
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide or budeosonide/formoterol administered by DPI<br>In every patient cough severity and tolerance of therapy will be analyzed during therapy with budesonide and/ or formoterol administered by DPI for 14 days | Device: Budesonid or budesonide/fomoterol administered by DPI<br>* Miflonide Breezhaler 200 mcg or Oxodil Aerolizer 12 mcg<br>* Other names: Miflonide or Miflonide and Oxodil;|
| Active Comparator: Budesonide or budeosonide/formoterol administered by MDI<br>In every patient inhaler will be changed and cough severity and tolerance of therapy will be analyzed during therapy with the same drugs administered by MDI . Order of using different types of inhalers will be accidental | Device: Budesonid or budesonide/fomoterol administered by MDI<br>* Budiair 200 mcg or Atimos 12 mcg<br>* Other names: Budiair or Budiair and Atimos;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in cough severity | Assessment by 10 mm Visual Analogue Scale | 14 days and 28 days | 
| change in cough related Quality of Life | Assessment by cough related Leicester Quality of Life Questionnaire (LCQ) | baseline ,14 and 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in asthma control | Assessment by Asthma Control Test | baseline , 14 and 28 days | 
| change in asthma related Quality of Life | Assessment by Asthma Quality of Life Questionnaire (AQLQ) | baseline ,14 and 28 days | 
| change in number of cough episodes counted per 2 hours | measured by investigator during visit | baseline, 14 and 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inhalation technique, Dry Powder Inhaler, pressurized Metered Dose Inhaler