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

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ClinicalTrials.gov Identifier: NCT01937390
Recruitment Status : Completed
First Posted : September 9, 2013
Results First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive 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

Study Design
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Study Type : Observational
Actual Enrollment : 645 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : November 6, 2011
Actual Primary Completion Date : October 22, 2016
Actual Study Completion Date : October 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Groups and Cohorts
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Group/Cohort Intervention/treatment
LAMA/LABA Patients Drug: Tiotropium 2x2.5µg tiotropium (equivalent to 2x3.154µg tiotropium bromide monohydrate) Respimat® inhaler and cartridge Solution for inhalation
Respimat® inhaler and cartridge Solution for inhalation

Drug: Indacterol 300 µg
inhalation powder

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

Drug: Indacterol 150 µg
inhalation powder


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Caucasians
Criteria

Inclusion criteria:

  1. Male or female, above 40 years of age

  2. Patients clinically diagnosed of COPD with no history suggestive of asthma:

    1. by scores >=5 in the COPD Population Screener,
    2. by a clinical diagnosis of COPD made by pulmonologists or internists,
    3. 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);
  3. 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
  4. Patients who are able to provide signed informed consent
  5. Patients who agree to be contacted for telephone/ SMS reminders via call center

Exclusion criteria:

  1. Patients with contraindications to the prescribed medication
  2. Patients with any disorder that would prevent the patient from being able to complete questionnaires either verbally or by self-completion
  3. Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937390


Locations
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Germany
CTMS MIGRATION CENTER representing all obvious CTMS Dummy Sites
Ingelheim am Rhein, Germany, 55216
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01937390    
Other Study ID Numbers: 205.517
First Posted: September 9, 2013    Key Record Dates
Results First Posted: July 27, 2018
Last Update Posted: July 27, 2018
Last Verified: October 2017
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Bromides
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants