Efficacy of Inhalation Technique Training.

Asthma Clinical Trial

Official title:

Impact of Inhalation Technique Training on the Course of Asthma and Chronic Obstructive Pulmonary Disease (COPD).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131454
• Other study ID #: WUM-TI
• Status: Completed
• Phase: N/A
• First received: May 3, 2014
• Last updated: November 29, 2016
• Start date: September 2013
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Bioethics Appeals Commission
• Study type: Interventional

Clinical Trial Summary

Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The aim of the study is to determine if short training of inhalation technique in patients with obstructive diseases may influence the course of asthma and COPD.

Description:

Both asthma and COPD are common medical problems. Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The inhalation technique is the key factor for effective management of bronchial obstruction. At the same time, a significant proportion of patients with asthma or COPD do not use inhalers properly.

The aim of the study is:

• to analyze the frequency and type of common mistakes in inhalation technique and

• to determine the impact of short individual training of inhalation technique on the course of asthma and COPD.

Fifty patients with asthma and 50 patients with COPD treated in the out-patient clinic or in the Department of Internal Medicine, Pneumonology and Allergology will be enrolled to the study.

The stage of severity (COPD) and control of the disease (asthma), quality of life, proper inhaler intake will be assessed at the study onset and at a second visit after 6 months.

At the second visit all patients will get a short, individual information about the etiology, course and general treatment plan of asthma / COPD. Patients will be randomized into two groups:

A. group of patients trained in proper inhalation technique B. group of patients without inhalation technique training Control visits will be held 3 and 6 months after training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:

• age of 18 - 80 years

• asthma or COPD diagnosed at least 6 months before study enrollment

• everyday usage of at least one of the following: pressured meter dose inhaler (pMDI) or dry powdered inhaler (Aerolizer, Handihaler, Disc or Turbuhaler)

• no other comorbidities that could influence learning of inhalation technique (psychiatric or neurologic disorders)

Exclusion criteria:

• age less than 18 or above 80 years

• lack of informed consent

• asthma or COPD diagnosed less than 6 months prior to screening visit

• coexistence of respiratory diseases other than asthma or COPD

• irregular use (not every day) of at least one inhaled drug

• treatment with inhalers other than: pMDI, Disc, Turbuhaler, Handihaler or Aerolizer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Other:
• Inhalation technique training
Training in inhalation technique in asthmatics and COPD patients

Locations

Country	Name	City	State
Poland	Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Al-Showair RA, Tarsin WY, Assi KH, Pearson SB, Chrystyn H. Can all patients with COPD use the correct inhalation flow with all inhalers and does training help? Respir Med. 2007 Nov;101(11):2395-401. — View Citation

Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri.. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Erratum in: Respir Med. 2012 May;106(5):757. DelDonno, Mario [corrected to Del Donno, Mario]. — View Citation

Press VG, Arora VM, Shah LM, Lewis SL, Charbeneau J, Naureckas ET, Krishnan JA. Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial. J Gen Intern Med. 2012 Oct;27(10):1317-25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease control.	Change from baseline in Asthma Control Test (ACT) or COPD Assessment Test (CAT)	baseline , 3 months , 6 months	No
Primary	Asthma or COPD exacerbations	The number and severity of asthma and COPD exacerbations.	6 months	No
Secondary	Quality of life.	Change from baseline in quality of life questionnaires: for asthma patients - Asthma Quality of Life Questionnaire for COPD patients - Saint George's Respiratory Questionnaire	baseline, 3 months, 6 months	No