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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04203472
Enrollment
22
Registered
2019-12-18
Start date
2019-01-20
Completion date
2022-03-30
Last updated
2022-05-23

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

Conditions

Asthma, Cough Variant Asthma

Keywords

inhalation technique, Dry Powder Inhaler, pressurized Metered Dose Inhaler

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.

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. 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.

Interventions

DEVICEBudesonid or budesonide/fomoterol administered by DPI

Miflonide Breezhaler 200 mcg or Oxodil Aerolizer 12 mcg

DEVICEBudesonid or budesonide/fomoterol administered by MDI

Budiair 200 mcg or Atimos 12 mcg

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

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 accidental

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
change in cough severity14 days and 28 daysAssessment by 10 mm Visual Analogue Scale
change in cough related Quality of Lifebaseline ,14 and 28 daysAssessment by cough related Leicester Quality of Life Questionnaire (LCQ)

Secondary

MeasureTime frameDescription
change in asthma controlbaseline , 14 and 28 daysAssessment by Asthma Control Test
change in asthma related Quality of Lifebaseline ,14 and 28 daysAssessment by Asthma Quality of Life Questionnaire (AQLQ)
change in number of cough episodes counted per 2 hoursbaseline, 14 and 28 daysmeasured by investigator during visit

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026