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Completed

NCT Number: NCT01937390

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

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

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CTMS MIGRATION CENTER representing all obvious CTMS Dummy Sites

Ingelheim, 55216, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Indacterol 300 µg

Drug

inhalation powder

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

Drug

HandiHaler® device Inhalation powder, hard capsule

Indacterol 150 µg

Drug

inhalation powder

Primary outcomes

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

    Time frame: Baseline and 13 Month

    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).

  2. CCQ Total Score at Month 13 (Visit 4)

    Time frame: 13 months

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

  3. Number of COPD Exacerbations Leading to Hospitalization, Per Patient

    Time frame: 13 months

    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.

  4. Number of COPD Exacerbations, Per Patient

    Time frame: 13 months

    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.

Secondary outcomes

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

    Time frame: 13 months

    Percentage of subjects corresponding to each reason of non-adherence to once-daily long-acting bronchodilators in COPD patients are presented.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Post-Marketing Observational Study of the Impact of Adherence to Treatment With Once-Daily Administered Long-Acting Bronchodilators (LABAs / LAMAs) on Patients Health Related Quality of Life in COPD Patients

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2013
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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