N/A
N=1,858
Changes in Physical Functioning in Patients With COPD During Therapy With a Combination Inhalation Therapy
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT02173769 ↗Enrolled (actual)
1,858
Serious AEs
2.3%
Results posted
Apr 2016
Primary outcome: Primary: Percentage of Participants With "Therapeutic Success" — 48.90; 51.10 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Spiriva® Respimat® (Drug); Striverdi® Respimat® (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With "Therapeutic Success" |
48.90; 51.10 | — |
| SECONDARY Absolute Changes in the PF-10 Score |
10.15 | — |
| SECONDARY General Health of the Patient at Baseline |
2.10; 14.72; 25.73; 29.13; 16.57; 9.44 | — |
| SECONDARY General Health of the Patient After 4-6 Weeks |
0.96; 5.48; 13.67; 22.60; 25.08; 22.09 | — |
| SECONDARY Patient Satisfaction: Overall Satisfaction |
25.21; 42.13; 13.53; 9.70; 4.29; 4.06 | — |
| SECONDARY Patient Satisfaction: Satisfaction With Inhaler |
31.53; 49.86; 10.06; 5.12; 1.52; 1.46 | — |
| SECONDARY Patient Satisfaction: Satisfaction With Handling of Inhaler |
31.44; 49.32; 11.25; 5.06; 1.57; 0.96 | — |
Summary
The decrease in physical activity due to increasing dyspnoea that over time leads to a steadily worsening condition and increasing restriction of physical functioning is a key problem for COPD patients and affects even the early stages.
Clinical studies to investigate both Spiriva® and Striverdi® Respimat® have demonstrated a marked improvement in physical exercise capacity.
However, there have so far been no data from the daily practice setting about everyday functioning on combination treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in patients requiring treatment with 2 long-acting bronchodilators.
The objective of this NIS is to measure changes in physical functioning as a surrogate for physical activity and exercise capacity in COPD patients on treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in routine daily treatment (so-called real life setting).
Eligibility Criteria
Inclusion criteria
- Female and male patients >= 40 years
- COPD GOLD 2014 B - D
- Treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat® acc. to the Summary of Product Characteristics (SmPC), no change of routine diagnostics and treatment
- Signed informed consent form before inclusion into the non-interventional study (NIS)
Exclusion criteria
- Patients with contraindications acc. to the Summary of Product Characteristics (SmPC)
- pregnant and breastfeeding women
- patients who are taking part in a different non-interventional study (NIS) or an interventional clinical study at the same time are not to be enrolled
Data sourced from ClinicalTrials.gov (NCT02173769). 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.