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

May 19, 2022 updated by: Marta Dąbrowska, Medical University of Warsaw

Influence of Type of Inhaler on Cough Severity and Tolerance of Therapy in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-097
        • Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in cough severity
Time Frame: 14 days and 28 days
Assessment by 10 mm Visual Analogue Scale
14 days and 28 days
change in cough related Quality of Life
Time Frame: baseline ,14 and 28 days
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
Time Frame: baseline , 14 and 28 days
Assessment by Asthma Control Test
baseline , 14 and 28 days
change in asthma related Quality of Life
Time Frame: baseline ,14 and 28 days
Assessment by Asthma Quality of Life Questionnaire (AQLQ)
baseline ,14 and 28 days
change in number of cough episodes counted per 2 hours
Time Frame: baseline, 14 and 28 days
measured by investigator during visit
baseline, 14 and 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2019

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

September 2, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (Actual)

December 18, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Inhaler in CVA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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