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A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663569
Recruitment Status : Completed
First Posted : September 10, 2018
Results First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Open-label observational study which includes COPD patients that are receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Spiolto® Respimat®

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Study Type : Observational
Actual Enrollment : 4819 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Changes in Clinical Control of COPD Patients Measured by the Clinical COPD Questionnaire During Therapy With Spiolto®Respimat® in Routine Clinical Practice
Actual Study Start Date : August 15, 2018
Actual Primary Completion Date : October 4, 2019
Actual Study Completion Date : October 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
subjects with COPD Drug: Spiolto® Respimat®
Drug




Primary Outcome Measures :
  1. Proportion of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2 [ Time Frame: At Visit 2 (6 weeks after baseline visit 1) ]
    Therapeutic success of Spiolto® Respimat® treatment was defined as 0.4 point decrease in the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire - Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Each of the 10 CCQ questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do) at baseline (Visit 1) and at the end of the observation after approximately 6 weeks (Visit 2). The sum of the scores divided by 10 gives the CCQ score, which measures the health and functional status. A higher CCQ score is indicative of worse status.


Secondary Outcome Measures :
  1. Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2 [ Time Frame: At baseline visit 1 and 6 weeks thereafter at visit 2 ]
    The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6 at baseline and at the end of observation after approximately 6 weeks. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. Change of the score was calculated as visit 2 minus visit 1.

  2. Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) [ Time Frame: At visit 1 ]
    PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).

  3. Physician's Global Evaluation (PGE) Score at Visit 2 [ Time Frame: At visit 2 (6 weeks after baseline visit 1) ]
    PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).

  4. Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 [ Time Frame: At visit 2 ]
    Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported.

  5. Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 [ Time Frame: At visit 2 ]
    Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported

  6. Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 [ Time Frame: At visit 2 ]
    Patient satisfaction with handling of the Respimat® inhalation device at visit 2 was reported.

  7. Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 [ Time Frame: At visit 2 ]
    Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 was reported.



Information from the National Library of Medicine

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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
Around 4500 COPD patients from approximately 11 countries will be collected, with a signed informed consent will be maintained in the ISF at the investigational site irrespective of whether they have been treated or not.
Criteria

Inclusion Criteria:

  • Written informed consent prior to participation
  • Female and male patients ≥40 years of age
  • Patients diagnosed with COPD and based upon the investigator's decision requiring a new prescription of Spiolto Respimat® (combination of two long-acting bronchodilators) according to Spiolto® Respimat® SmPC, GOLD COPD Strategy Document 2018 (GOLD COPD groups B to D) and local COPD guidelines

Exclusion Criteria:

  • Patients with contraindications according to Spiolto® Respimat® SmPC
  • Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry
  • Patients continuing LABA/ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
  • Pregnancy and lactation
  • Current participation in any clinical trial or any other non-interventional study of a drug or device.

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): NCT03663569


Locations
Show Show 388 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Alexey Medvedchikov, +431801057896 alexey.medvedchikov@boehringer-ingelheim.com
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] March 26, 2018
Statistical Analysis Plan  [PDF] July 19, 2019

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03663569    
Other Study ID Numbers: 1237-0072
First Posted: September 10, 2018    Key Record Dates
Results First Posted: October 22, 2020
Last Update Posted: October 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studiesin products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).Requestors can use the following link http://trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive