Clinical trial NCT04203472: Optimal Type of Inhaler in Cough Variant- or Cough Predominant Asthma
Official title: Influence of Type of Inhaler on Cough Severity and Tolerance of Therapy in Patients With Cough Variant or Cough Predominant Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Cough Variant Asthma
Keywords: inhalation technique
Dry Powder Inhaler
pressurized Metered Dose Inhaler
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: change in cough severity
timeFrame: 14 days and 28 days
measure: change in cough related Quality of Life
timeFrame: baseline ,14 and 28 days
Secondary outcomes:
measure: change in asthma control
timeFrame: baseline , 14 and 28 days
measure: change in asthma related Quality of Life
timeFrame: baseline ,14 and 28 days
measure: change in number of cough episodes counted per 2 hours
timeFrame: baseline, 14 and 28 days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
Study officials:
References:
citation: Morice AH, McGarvey L, Pavord I; British Thoracic Society Cough Guideline Group. Recommendations for the management of cough in adults. Thorax. 2006 Sep;61 Suppl 1(Suppl 1):i1-24. doi: 10.1136/thx.2006.065144. No abstract available.
citation: Irwin RS, Baumann MH, Bolser DC, Boulet LP, Braman SS, Brightling CE, Brown KK, Canning BJ, Chang AB, Dicpinigaitis PV, Eccles R, Glomb WB, Goldstein LB, Graham LM, Hargreave FE, Kvale PA, Lewis SZ, McCool FD, McCrory DC, Prakash UBS, Pratter MR, Rosen MJ, Schulman E, Shannon JJ, Hammond CS, Tarlo SM. Diagnosis and management of cough executive summary: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):1S-23S. doi: 10.1378/chest.129.1_suppl.1S. No abstract available.
citation: Inhaler Error Steering Committee; Price D, Bosnic-Anticevich S, Briggs A, Chrystyn H, Rand C, Scheuch G, Bousquet J. Inhaler competence in asthma: common errors, barriers to use and recommended solutions. Respir Med. 2013 Jan;107(1):37-46. doi: 10.1016/j.rmed.2012.09.017. Epub 2012 Oct 23.
citation: Price DB, Roman-Rodriguez M, McQueen RB, Bosnic-Anticevich S, Carter V, Gruffydd-Jones K, Haughney J, Henrichsen S, Hutton C, Infantino A, Lavorini F, Law LM, Lisspers K, Papi A, Ryan D, Stallberg B, van der Molen T, Chrystyn H. Inhaler Errors in the CRITIKAL Study: Type, Frequency, and Association with Asthma Outcomes. J Allergy Clin Immunol Pract. 2017 Jul-Aug;5(4):1071-1081.e9. doi: 10.1016/j.jaip.2017.01.004. Epub 2017 Mar 9.
citation: Kamimura M, Izumi S, Hamamoto Y, Morita A, Toyota E, Kobayashi N, Kudo K. Superiority of nebulized corticosteroids over dry powder inhalers in certain patients with cough variant asthma or cough-predominant asthma. Allergol Int. 2012 Sep;61(3):411-7. doi: 10.2332/allergolint.11-OA-0357. Epub 2012 May 25.