Clinical trial NCT02131454: Efficacy of Inhalation Technique Training.
Official title: Impact of Inhalation Technique Training on the Course of Asthma and Chronic Obstructive Pulmonary Disease (COPD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Keywords: asthma and COPD treatment
inhalation techniques
training of inhalation
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Asthma or COPD exacerbations
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life.
timeFrame: baseline, 3 months, 6 months
Other outcomes:
measure: Disease control.
timeFrame: baseline , 3 months , 6 months
Locations:
city: Warsaw
country: Poland
facility: Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
Study officials:
References:
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. Epub 2011 Mar 2.
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. doi: 10.1007/s11606-012-2090-9. Epub 2012 May 17.
citation: 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. doi: 10.1016/j.rmed.2007.06.008. Epub 2007 Jul 12.
citation: Dabrowska M, Luczak-Wozniak K, Miszczuk M, Domagala I, Lubanski W, Leszczynski A, Maskey-Warzechowska M, Rubinsztajn R, Hermanowicz-Salamon J, Krenke R. Impact of a Single Session of Inhalation Technique Training on Inhalation Skills and the Course of Asthma and COPD. Respir Care. 2019 Oct;64(10):1250-1260. doi: 10.4187/respcare.06740. Epub 2019 Jun 18.