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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. Identifier: NCT03663569
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : November 25, 2019
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 : 4825 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®

Primary Outcome Measures :
  1. Therapeutic success at visit 2 (0.4 point decrease in the Clinical COPD Questionnaire - CCQ score from visit 1 to visit 2) [ Time Frame: up to 6 weeks ]
    (0.4 point decrease in the Clinical COPD Questionnaire - CCQ score from visit 1 to visit 2).

Secondary Outcome Measures :
  1. Assessment of 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: up to 6 weeks ]
  2. Physician's Global Evaluation (PGE score) at visit 1(baseline) and visit 2 [ Time Frame: up to 6 weeks ]
    general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent)

  3. Patient Satisfaction Questionnaire score with Spiolto® Respimat® at visit 2 [ Time Frame: up to 6 weeks ]
    Score range 1-7

  4. Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 [ Time Frame: up to 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT03663569

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Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Alexey Medvedchikov, +431801057896
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Responsible Party: Boehringer Ingelheim Identifier: NCT03663569    
Other Study ID Numbers: 1237-0072
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
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 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