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

NCT04203472 | Completed

• 1 other identifier: Inhaler in CVA
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Cough Variant Asthma

Keywords

inhalation technique; Dry Powder Inhaler; pressurized Metered Dose Inhaler

Outcome Measures

Primary Outcomes (2)

• change in cough severity

  Assessment by 10 mm Visual Analogue Scale

  14 days and 28 days

• change in cough related Quality of Life

  Assessment by cough related Leicester Quality of Life Questionnaire (LCQ)

  baseline ,14 and 28 days

Secondary Outcomes (3)

• change in asthma control

  baseline , 14 and 28 days

• change in asthma related Quality of Life

  baseline ,14 and 28 days

• change in number of cough episodes counted per 2 hours

  baseline, 14 and 28 days

Study Arms (2)

Budesonide or budeosonide/formoterol administered by DPI

EXPERIMENTAL

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

Budesonide or budeosonide/formoterol administered by MDI

ACTIVE COMPARATOR

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

Interventions

Budesonid or budesonide/fomoterol administered by DPI DEVICE

Miflonide Breezhaler 200 mcg or Oxodil Aerolizer 12 mcg

Also known as: Miflonide or Miflonide and Oxodil

Budesonide or budeosonide/formoterol administered by DPI

Budesonid or budesonide/fomoterol administered by MDI DEVICE

Budiair 200 mcg or Atimos 12 mcg

Also known as: Budiair or Budiair and Atimos

Budesonide or budeosonide/formoterol administered by MDI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw

Warsaw, 02-097, Poland

Location

Related Publications (5)

• 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.

  PMID: 16936230 RESULT

• 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.

  PMID: 16428686 RESULT

• 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.

  PMID: 23098685 RESULT

• 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.

  PMID: 28286157 RESULT

• 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.

  PMID: 22627846 RESULT

MeSH Terms

Conditions

Asthma; Cough-Variant Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Researcher

Model Details: 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

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: December 18, 2019
• Study Start: January 20, 2019
• Primary Completion: February 28, 2022
• Study Completion: March 30, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

PL (1)