N/A
Completed N=95
SMS Reminder to Assess Adherence
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01308476 ↗
Enrolled (actual)
95
Serious AEs
4.2%
Results posted
Dec 2012
Primary outcomePrimary: Adherence to Spiriva HandiHaler Over Time — 99.0; 96.2; 99.5; 99.5 Percentage of applications
Summary
6 months open label non-interventional observational study acc to § 4, section 23 and § 67, section 6 German Medicines Act with two parallel groups
1. the SMS group receiving a daily SMS - a reminder to inhale Spiriva® 18 Microgram
2. the control group not receiving a daily SMS reminder
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to Spiriva HandiHaler Over Time |
99.0; 96.2; 99.5; 99.5; 100.0; 98.6 | — |
| SECONDARY Change From Baseline in Adherence to Spiriva HandiHaler Over Time |
0.6; 3.7; 0.0; 2.5; 0.0; 0.7 | — |
| SECONDARY Response Rate Regarding Adherence |
55.3; 64.4; 44.7; 35.6 | — |
| SECONDARY Patients Compliance With SMS System |
55.0; 64.1 | — |
| SECONDARY Patients Assessment of Usefulness of the SMS System |
12.8; 61.7; 23.4; 2.1; 8.9; 53.3 | — |
| SECONDARY Physicians Assessment of Usefulness of the SMS System |
6.4; 87.2; 6.4; 0.0; 11.1; 80.0 | — |
| SECONDARY Physicians Recommendation of the SMS System |
8.5; 70.2; 21.3; 8.9; 64.4; 26.7 | — |
| SECONDARY Patients Satisfaction With SMS System |
23.4; 42.6; 21.3; 6.4; 2.1; 4.3 | — |
Eligibility Criteria
Inclusion criteria
- Chronic obstructive pulmonary disease (COPD) patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines
- User of mobile phone
Exclusion criteria
- Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the SPC
Data sourced from ClinicalTrials.gov (NCT01308476). 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. Informational only — not medical advice.