N/A
N=585
Observational Study of Adherence to LABA / LAMA in Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01937390 ↗Enrolled (actual)
585
Serious AEs
1.7%
Results posted
Jul 2018
Primary outcome: Primary: Clinical COPD Questionnaire (CCQ) Total Score Change From Baseline at Month 13 — -1.55 Units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tiotropium 2x2.5µg tiotropium (equivalent to 2x3.154µg tiotropium bromide monohydrate) Respimat® inhaler and cartridge Solution for inhalation (Drug); Indacterol 300 µg (Drug); Tiotropium 18µg (equivalent to 22.5µg tiotropium bromide monohydrate) HandiHaler® device Inhalation powder, hard capsule (Drug); Indacterol 150 µg (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical COPD Questionnaire (CCQ) Total Score Change From Baseline at Month 13 |
-1.55 | — |
| PRIMARY CCQ Total Score at Month 13 (Visit 4) |
2.03 | — |
| PRIMARY Number of COPD Exacerbations Leading to Hospitalization, Per Patient |
1.7; 0.7; 0.3; 0.5 | — |
| PRIMARY Number of COPD Exacerbations, Per Patient |
12.5; 3.8; 3.2; 2.2; 0.7; 0.9 | — |
| SECONDARY Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients |
1.9; 1.2; 0.9; 0.2; 0.2; 0.2 | — |
Summary
The objective of the study is to observe the effect of adherence to once-daily administered long-acting bronchodilators (long-acting ß2-agonists [LABAs] / long-acting muscarinic antagonists [LAMAs]) on patients health related quality of life (HR-QoL) and to assess the relation between symptoms improvement and adherence to Chronic Obstructive Pulmonary Disease (COPD) maintenance therapy
Eligibility Criteria
Inclusion criteria
- Male or female, above 40 years of age
- Patients clinically diagnosed of COPD with no history suggestive of asthma:
- by scores >=5 in the COPD Population Screener,
- by a clinical diagnosis of COPD made by pulmonologists or internists,
- by a Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC6) ratio of <=0.70 and a FEV1 <=80% of the predicted value as assessed by copd-6 (Vitalograph, UK);
- Maintenance treatment-naïve COPD patients who have been prescribed once daily long-acting bronchodilators (LABAs / LAMAs) for the first time at enrolment into the study
- Patients who are able to provide signed informed consent
- Patients who agree to be contacted for telephone/ SMS reminders via call center
Exclusion criteria
- Patients with contraindications to the prescribed medication
- Patients with any disorder that would prevent the patient from being able to complete questionnaires either verbally or by self-completion
- Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception
Data sourced from ClinicalTrials.gov (NCT01937390). 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.