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N/A N=165 Randomized Single-blind Supportive Care

Intervention to Improve Inhalative Adherence

Chronic Asthma · COPD

Enrolled (actual)
165
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Time to Next Asthma or COPD Exacerbation up to 182 Days — 172; 161 days to first exacerbation

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Electronic Monitoring with audio reminders and additional support (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Cantonal Hosptal, Baselland
Primary completion
Apr 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to Next Asthma or COPD Exacerbation up to 182 Days
172; 161
SECONDARY
Number of Exacerbations.
0.3; 0.5
SECONDARY
Number of Severe Exacerbations.
0.08; 0.08
SECONDARY
Adherence to Puff Inhalers
81.6; 60.1
SECONDARY
Percentage of Days With Adherence to Dry Powder Capsules (Breezhaler and Handihaler) Assessed by POEMS
89.6; 80.2
SECONDARY
Percentage of Days of Adherence
68.9; 50.6
SECONDARY
Percentage of Days With Timing Adherence
79.6; 71.7
SECONDARY
Percentage of Gaps in Puff Inhaler Use
3.2; 11.7
SECONDARY
Percentage of Gaps for Dry Powder Capsules (Breezhaler, Handihaler), Assessed by POEMS.
4.6; 9.8
SECONDARY
Numbers of Days of the Longest Period of Time Without Inhalation During the Investigated Time Period
1.6; 11.6
SECONDARY
Number of Days of the Longest Period of Time Without Inhalation.
2.6; 5.9
SECONDARY
Score of the St. George Respiratory Questionnaire
45.7; 48.7; 45.2; 52.4; 21.8; 29.3

Summary

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.

Eligibility Criteria

Inclusion:

  • Aged 18 years or older
  • Have an established asthma-diagnosis according to the Global Initiative for Asthma (GINA) guidelines and/or
  • Have an established COPD diagnosis according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (severity GOLD I-IV based on the international GOLD-Criteria) [46] and
  • Are prescribed daily inhaled medication (controller medication for a daily maintenance treatment)
  • Had at least one exacerbation in the previous 12 months before study start
  • With a metered dose Inhaler (e.g. Ventolin®), Diskus (e.g.Seretide®), Turbohaler (e.g.Symbicort®), Aerolizer/Breezhaler (e.g.Onbrez®), HandiHaler (e.g. Spiriva®) or Ellipta (e.g Relvar®)

Exclusion:

  • Suffering from malignancies and/or other severe diseases
  • Insufficient in the German language
  • Pregnant or lactating
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02386722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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