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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

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ClinicalTrials.gov Identifier: NCT03663569
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : March 27, 2019
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
Estimated Enrollment : 4500 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
Estimated Primary Completion Date : May 28, 2019
Estimated Study Completion Date : May 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

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




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

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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


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Contact: Ingelheim

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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Alexey Medvedchikov, +431801057896 alexey.medvedchikov@boehringer-ingelheim.com

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03663569     History of Changes
Other Study ID Numbers: 1237-0072
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 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 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
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
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