Intervention to Improve Inhalative Adherence
Intervention to Improve Inhalative Adherence
Asthma and chronic obstructive pulmonary disease (COPD) are common lung. Despite the
 important progresses achieved in treatments, the majority of affected patients suffer from
 severe symptoms and tend to be frequently hospitalised due to exacerbation. Reasons for
 uncontrolled asthma and COPD are manifold, but often a poor inhalation technique and a poor
 following of the prescribed treatment plan is observed, which is called non-adherence.

 The primary aim of this study will therefore be to measure medication adherence in patients
 with chronic obstructive lung diseases, and to investigate the impact of an audio reminder on
 disease outcomes and quality of life.

 The investigators hypotheses will be that an adherence reminder, improve medication adherence
 and that a good medication adherence elongate the time to next exacerbation in patients with
 chronic obstructive lung diseases.

 A prospective single-blind randomized controlled study is planned, where the investigators
 are going to analyse the adherence over a period of six months of in- and outpatients, who
 have experienced at least one exacerbation during the last year. The adherence of
 intervention- and control group will be measured by specific electronic data capture devices
 which can save each actuation with date and time. Patients assigned to the intervention group
 will be reminded for the inhalation by an audio reminder and will receive support calls if
 medication will not be taken as prescribed or if rescue medication will be used too often. In
 contrast, the control group, will not be reminded and will not receive any calls, if do not
 comply with the prescribed medication schedule or if they use their rescue medication too
 frequently.

 During study period, participants will be assessed every two months. Each assessment will
 include spirometry, measurement of diffusion capacity, exhaled nitric oxide and carbon
 monoxide. Moreover participants will demonstrate their inhalation techniques by using placebo
 devices and fill out questionnaires regarding quality of life.

 Statistical significance will be acquired if a p value of less than 0.05 is attained. Time to
 next exacerbation will be compared using the Kaplan-Meier method and Cox proportional hazard
 model. Results will be reported as HR (hazard ratio) with corresponding 95% confidence
 interval (CI) and p-value.

 "Time to next exacerbation" is subject to the investigators power calculation. A previous
 study has shown that 30% of COPD patients are readmitted again within six month because of an
 exacerbation. The investigators expect that 12% of patients in the intervention group will
 have an exacerbation. This corresponds to a hazard ratio of 0.36. Assuming a sample size of
 70 subjects for each study group, there is a power of 80% to detect a HR of 0.36 based on a
 one-tailed test. Additional 14 subjects (7 for each study group) have been added to account
 for drop outs. Therefore, 154 subjects will be investigated in this study.
Inclusion Criteria:

 -  In- and outpatients older than 18 years, who have a clinical diagnosis of asthma or
 COPD

 -  At least one exacerbation in the last year

 -  Participants need to be able to give informed consent.

 -  A good knowledge of the German language by themselves.

 -  Patients 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 Criteria:

 -  Patients who have other lung diseases than asthma and COPD

 -  Subjects with severe diseases (e.g. active carcinoma, major depression)

 -  Pregnant or lactating women