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Re-usable Respimat® Soft MistTM Inhaler Study

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: NCT04011735
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The study is to assess patient satisfaction with the inhaler attributes of the re-usable Respimat SMI (Spiriva, Striverdi or Spiolto) in patients with COPD, including patients who are Respimat SMI-experienced and Respimat SMI-naïve. This study also aims to examine patient preference for the re-usable Respimat SMI compared to the disposable Respimat SMI in Respimat SMI-experienced patients switching from a disposable to a re-usable Respimat SMI product at study entry.

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

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Study Type : Observational
Actual Enrollment : 262 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Real-world Non-interventional Study to Assess Patient Satisfaction With and Preference for Re-usable Respimat Soft Mist Inhaler in Patients With Chronic Obstructive Pulmonary Disease.
Actual Study Start Date : September 30, 2019
Actual Primary Completion Date : February 13, 2020
Actual Study Completion Date : February 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
Respimat SMI-experienced
patients who have been on maintenance treatment with a Respimat SMI product and receive a refill prescription at study entry
Drug: Respimat
Soft Mist Inhaler product
Other Names:
  • (Spiriva®, Striverdi® or
  • Spiolto®)

Respimat SMI-naïve
patients who have not previously used a Respimat SMI product and receive their first prescription at study entry
Drug: Respimat
Soft Mist Inhaler product
Other Names:
  • (Spiriva®, Striverdi® or
  • Spiolto®)




Primary Outcome Measures :
  1. mean total Patient Satisfaction and Preference Questionnaire (PASAPQ score) [ Time Frame: upto 6 weeks ]

Secondary Outcome Measures :
  1. Total performance PASAPQ score for all patients at study end (follow-up assessment) [ Time Frame: upto 6 weeks ]
  2. Total convenience PASAPQ score for all patients at study end (follow-up assessment) [ Time Frame: upto 6 weeks ]
  3. Overall satisfaction question with inhaler for all patients at study end (follow-up assessment) [ Time Frame: upto 6 weks ]
  4. Question on willingness to continue with inhaler for all patients at study end (follow-up assessment) [ Time Frame: upto 6 weeks ]
  5. Questions on ease of handling of the re-usable Respimat SMI for all patients at study end (follow-up assessment) [ Time Frame: upto 6 weeks ]
  6. Difference in the mean total PASAPQ score between study entry (baseline visit) and study end (follow-up assessment) in Respimat SMI-experienced patients switching from a disposable to a re-usable Respimat SMI product at study entry [ Time Frame: upto 6 weeks ]
  7. Question on preference for re-usable or disposable Respimat SMI at study end (follow-up assessment) in Respimat SMI-experienced patients switching from a disposable to a re-usable Respimat SMI product at study entry [ Time Frame: upto 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:   Probability Sample
Study Population
The study is planned that approximately with 250 Chronic Obstructive Pulmonary Disease (COPD) patients (Respimat SMI-experienced and Respimat SMI-naïve) from Europe will be enrolled in this study.
Criteria

Inclusion Criteria:

Patients fulfilling all the following inclusion criteria will be eligible for participation in the study:

  • Provision of signed informed consent prior to study data collection
  • Patient with COPD aged 40 years or older
  • Patient prescribed (or already receiving the disposable Respimat SMI and switched to) one of the following re-usable Respimat SMI products per the standard clinical practice: Spiriva 2.5 microgram inhalation solution; (2) Striverdi 2.5 microgram inhalation solution; and (3) Spiolto 2.5 microgram / 2.5 microgram inhalation solution
  • Patient unlikely to change their Respimat therapy during the 4-6 week observation period (in the opinion of the investigator)

Exclusion Criteria:

Patients fulfilling any of the following exclusion criteria will not be eligible for participation in the study:

  • Patient using a disposable Respimat SMI product during the study period
  • Patient who have had a severe COPD exacerbation requiring hospitalisation in the immediate 3 months prior to study entry
  • Patient participating in a clinical trial or any other non-interventional study of a drug or device at the time of enrolment
  • Visual, cognitive, motor or health impairment that, as judged by the investigator, may cause concern regarding the patient's ability to complete the questionnaires
  • Patient not fluent and literate in one of the main languages of the country

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): NCT04011735


Locations
Show Show 22 study locations
Sponsors and Collaborators
Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04011735    
Other Study ID Numbers: 1237-0097
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
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: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
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