NCT02131454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

May 3, 2014

Last Update Submit

November 29, 2016

Conditions

AsthmaChronic Obstructive Pulmonary Disease

Keywords

asthma and COPD treatmentinhalation techniquestraining of inhalation

Outcome Measures

Primary Outcomes (1)

  • Asthma or COPD exacerbations

    The number and severity of asthma and COPD exacerbations.

    6 months

Secondary Outcomes (1)

  • Quality of life.

    baseline, 3 months, 6 months

Other Outcomes (1)

  • Disease control.

    baseline , 3 months , 6 months

Study Arms (2)

Education and Inhalation technique training

EXPERIMENTAL

Training in technique of drug inhalation in asthma and COPD patients and education about the role of inhalation therapy in the course of the disease.

Other: Inhalation technique training

Education

NO INTERVENTION

Basic education about asthma and COPD.

Interventions

Inhalation technique trainingOTHER

Training in inhalation technique in asthmatics and COPD patients

Education and Inhalation technique training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Warsaw, 02-097, Poland

Location

Related Publications (4)

  • 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.

    PMID: 21367593BACKGROUND

  • 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.

    PMID: 22592354BACKGROUND

  • 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.

    PMID: 17629471BACKGROUND

  • 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.

    PMID: 31213572DERIVED

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 3, 2014

First Posted

May 6, 2014

Study Start

September 1, 2013

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

November 30, 2016

Record last verified: 2016-11

Locations

PL(1)