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