NCT02386722

Impact of a Pharmaceutical Care Intervention to Improve Adherence of Inhaled Medication in Asthma and COPD Patients

Completed NA Results posted Last updated 25 February 2025

What this trial tests

NA trial testing Electronic Monitoring with audio reminders and additional support in Chronic Asthma in 169 participants. Completed in 1 April 2017.

Timeline

1 January 2014

Primary endpoint
1 April 2017

1 April 2017

Quick facts

Lead sponsor	Cantonal Hosptal, Baselland
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	169
Start date	1 January 2014
Primary completion	1 April 2017
Estimated completion	1 April 2017
Sites	2 locations across Switzerland

Drugs / interventions tested

• Electronic Monitoring with audio reminders and additional support

Conditions studied

• Chronic Asthma — all drugs for Chronic Asthma →
• COPD — all drugs for COPD →

Sponsor

Cantonal Hosptal, Baselland

Who can join

18 and older, any sex, with Chronic Asthma or COPD. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Time to Next Asthma or COPD Exacerbation up to 182 Days
  Time frame: 182 days
  The primary outcome of this study was "time to next asthma or COPD exacerbation", defined as acute-onset worsening of the patient's condition beyond day-to-day variations requiring interaction with a healthcare provider. It was expressed as the number of exacerbations since the last visit with the exact period of exacerbation also including the number of exacerbations requiring hospitalisation. Th

Sponsor's own description

Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitalized due to exacerbations. Reasons for uncontrolled disease are manifold, but are frequently associated with poor inhalation technique and non-adherence to the prescribed treatment plan which may cause substantial mortality, morbidity, and cost to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase respectively maintain treatment adherence, particularly in chronic diseases, is of major clinical importance.

The aim of this study was to investigate the impact of an acoustic reminder and a close supervision on adherence to inhaled medication and on course of disease and quality of life (Qol) in asthma and COPD patients.

In this single-blinded trial, asthma and/or COPD patients were randomly assigned either to the intervention or the control group. Adherence to inhaled medication was monitored using electronic data capture devices, recording date and time of each inhalation device actuation. Follow-up was six months. Primary outcome was defined as "time to next exacerbation". Secondary outcomes included number of exacerbations, number of exacerbations with hospitalization, taking/timing adherence, and Qol during follow-up. Adherence was measured using electronic data capture devices which saved date and time of each inhalative device actuation. Patients are randomly assigned to an intervention, respectively control group. Patients assigned to the intervention group will receive audio reminder and support calls in case medication is not been taken as prescribed or if rescue medication is used more frequently than prespecified in the study protocol. During the study, participants are assessed every two months.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions to improve adherence to inhaled steroids for asthma.
   Normansell R, Kew KM, Stovold E. · · 2017 · cited 104× · PMID 28417456 · DOI 10.1002/14651858.cd012226.pub2
2. Use and inhalation technique of inhaled medication in patients with asthma and COPD: data from a randomized controlled trial.
   Gregoriano C, Dieterle T, Breitenstein AL, Dürr S, et al · · 2018 · cited 68× · PMID 30509268 · DOI 10.1186/s12931-018-0936-3
3. Interventions to improve adherence to pharmacological therapy for chronic obstructive pulmonary disease (COPD).
   Janjua S, Pike KC, Carr R, Coles A, et al · · 2021 · cited 35× · PMID 34496032 · DOI 10.1002/14651858.cd013381.pub2
4. Does a tailored intervention to promote adherence in patients with chronic lung disease affect exacerbations? A randomized controlled trial.
   Gregoriano C, Dieterle T, Breitenstein AL, Dürr S, et al · · 2019 · cited 32× · PMID 31796013 · DOI 10.1186/s12931-019-1219-3
5. Impact of an Electronic Monitoring Intervention to Improve Adherence to Inhaled Medication in Patients with Asthma and Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomized Controlled Trial.
   Gregoriano C, Dieterle T, Dürr S, Arnet I, et al · · 2017 · cited 12× · PMID 29061556 · DOI 10.2196/resprot.7522