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

Sponsor

Medical University of Warsaw (Other)

Overall Status

Completed

CT.gov ID

NCT04203472

Collaborator

(none)

Enrollment

Location

Arms

38.3

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma Cough Variant Asthma	Device: Budesonid or budesonide/fomoterol administered by DPI Device: Budesonid or budesonide/fomoterol administered by MDI	N/A

Detailed Description

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Intervention 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 accidentalIn 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)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 20, 2019

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Mar 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Budesonide or budeosonide/formoterol administered by DPI 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 Miflonide Breezhaler 200 mcg or Oxodil Aerolizer 12 mcg Other Names: Miflonide or Miflonide and Oxodil
Active Comparator: Budesonide or budeosonide/formoterol administered by MDI 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 Budiair 200 mcg or Atimos 12 mcg Other Names: Budiair or Budiair and Atimos

Arm

Intervention/Treatment

Experimental: Budesonide or budeosonide/formoterol administered by DPI

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

Miflonide Breezhaler 200 mcg or Oxodil Aerolizer 12 mcg

Other Names:

Miflonide or Miflonide and Oxodil

Active Comparator: Budesonide or budeosonide/formoterol administered by MDI

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

Budiair 200 mcg or Atimos 12 mcg

Other Names:

Budiair or Budiair and Atimos

Outcome Measures

Primary Outcome Measures

change in cough severity [14 days and 28 days]
Assessment by 10 mm Visual Analogue Scale
change in cough related Quality of Life [baseline ,14 and 28 days]
Assessment by cough related Leicester Quality of Life Questionnaire (LCQ)

Secondary Outcome Measures

change in asthma control [baseline , 14 and 28 days]
Assessment by Asthma Control Test
change in asthma related Quality of Life [baseline ,14 and 28 days]
Assessment by Asthma Quality of Life Questionnaire (AQLQ)
change in number of cough episodes counted per 2 hours [baseline, 14 and 28 days]
measured by investigator during visit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).