Observational Study of Adherence to LABA / LAMA in Chronic Obstructive Pulmonary Disease (COPD)

NCT01937390 | Completed Results

• 1 other identifier: 205.517
• Study Type: observational
• Target: 645
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (4)

• Clinical COPD Questionnaire (CCQ) Total Score Change From Baseline at Month 13

  The Clinical COPD (Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) is a standardized, validated and reliable questionnaire (in local language) to assess the impact of treatment on health status in COPD patients. CCQ total score is calculated as the arithmetic average of 10 individual scores on a 7-point scale. CCQ total score varies from 0 (very good control) to 6 (extremely poor control). Mean change in CCQ total score from baseline at month 13 is presented along with its standard error. Change in CCQ total score is calculated for each subject as: CCQ total score at month 13 - CCQ total score at baseline. Baseline is defined as the first assessment after enrolment (at Month 1).

  Baseline and 13 Month

• CCQ Total Score at Month 13 (Visit 4)

  Mean and standard deviation of CCQ total score is presented at month 13.

  13 months

• Number of COPD Exacerbations Leading to Hospitalization, Per Patient

  Percentage of subjects hospitalized due to COPD exacerbations exactly "n" number of times during the study period is presented. Here, "n" represents the number of times each subject is hospitalized due to COPD exacerbations.

  13 months

• Number of COPD Exacerbations, Per Patient

  Percentage of subjects experienced COPD exacerbations exactly "n" number of times during the study period is presented. Here, "n" represents the number of times each subject experienced COPD exacerbations.

  13 months

Secondary Outcomes (1)

• Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients

  13 months

Study Arms (1)

LAMA/LABA Patients

Drug: 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

Interventions

Tiotropium 2x2.5µg tiotropium (equivalent to 2x3.154µg tiotropium bromide monohydrate) Respimat® inhaler and cartridge Solution for inhalation DRUG

Respimat® inhaler and cartridge Solution for inhalation

LAMA/LABA Patients

Indacterol 300 µg DRUG

inhalation powder

LAMA/LABA Patients

Tiotropium 18µg (equivalent to 22.5µg tiotropium bromide monohydrate) HandiHaler® device Inhalation powder, hard capsule DRUG

HandiHaler® device Inhalation powder, hard capsule

LAMA/LABA Patients

Indacterol 150 µg DRUG

inhalation powder

LAMA/LABA Patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caucasians

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CTMS MIGRATION CENTER representing all obvious CTMS Dummy Sites

Ingelheim, 55216, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Inhalation; Tiotropium Bromide; Hardness

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Mechanical Phenomena; Physical Phenomena

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 9, 2013
• Study Start: November 6, 2011
• Primary Completion: October 22, 2016
• Study Completion: October 22, 2016
• Last Updated: July 27, 2018
• Results First Posted: July 27, 2018

Record last verified: 2017-10

Locations

DE (1)