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Impact of Tiotropium Add-on Therapy in Patients With Asthma

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: NCT03964220
Recruitment Status : Active, not recruiting
First Posted : May 27, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To evaluate the effectiveness of add on therapy with Tiotropium Respimat® compared to increasing the dose of ICS in patients with a diagnosis of Asthma and on ICS/LABA therapy

Condition or disease Intervention/treatment
Asthma Drug: Tiotropium Respimat® Drug: Inhaled Corticosteroid/Long-acting beta-agonist

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Study Type : Observational
Actual Enrollment : 6300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Effectiveness of Tiotropium Add-on Therapy Using a Real-world Cohort of Patients With Asthma
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : July 16, 2019
Estimated Study Completion Date : July 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Patients with Asthma Drug: Tiotropium Respimat®
Tiotropium Respimat® 1.25 mcg (on top of baseline Inhaled Corticosteroid/Long-acting beta-agonist )

Drug: Inhaled Corticosteroid/Long-acting beta-agonist
baseline low dose to medium/high dose, baseline medium dose ICS/LABA to high dose ICS/LABA, additional prescription/refill of high-dose-ICS/LABA following the first prescription of baseline high dose ICS/LABA




Primary Outcome Measures :
  1. time to first exacerbation per person [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Rate of exacerbation [ Time Frame: Up to 3 years ]
  2. Health Care Resource Utilization (HCRU) [ Time Frame: Up to 3 years ]
  3. Change in lung function at baseline and follow up period [ Time Frame: Up to 3 years ]
  4. Change in Asthma control test at baseline and in the follow up period [ Time Frame: Up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Asthmatics 6 years and above on ICS/LABA at baselineIMS Pharmetrics (IMS or Database I); EMRClaims+ (Database II)
Criteria

Inclusion Criteria:

  • Patients with least one asthma diagnosis in the inpatient setting or at least two separate instances of asthma diagnosis (separated by at least 30 days) recorded in the outpatient or emergency room setting will be included.
  • Patients will be required to be already on Inhaled Corticosteroid/Long-acting beta-agonist (ICS/LABA).
  • Patients will be required to have available records 12 months prior to the index date.

Exclusion Criteria:

  • Patients below the age of 6 years on the Inhaled Corticosteroid/Long-acting beta-agonist initiation (ICS/LABAi) date will be excluded.
  • Patients with a diagnosis of COPD at any time during the study period will be excluded.
  • Those who are on biologics at baseline will be removed.
  • After the PSM process, unmatched patients will be excluded.

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): NCT03964220


Locations
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United States, New York
eMax Health
White Plains, New York, United States, 10601
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03964220     History of Changes
Other Study ID Numbers: 0205-0543
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer‐ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://trials.boehringer‐ingelheim.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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