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OTIVACTO Regional Center Vienna (RCV) Non-Interventional Study (NIS)

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ClinicalTrials.gov Identifier: NCT02719639
Recruitment Status : Completed
First Posted : March 25, 2016
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date March 1, 2016
First Posted Date March 25, 2016
Results First Submitted Date May 29, 2018
Results First Posted Date January 9, 2019
Last Update Posted Date January 9, 2019
Actual Study Start Date April 1, 2016
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2019)
Percentage of Patients With Therapeutic Success After Approximately 6 Weeks. [ Time Frame: Approximately 6 weeks ]
The therapeutic success was defined as a minimum of 10- point increase in the Physical Functioning (PF-10) score between visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1), having approximately time period of 6 weeks between the evaluated questionnaires. PF-10 score measures changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients.
Original Primary Outcome Measures
 (submitted: March 21, 2016)
Primary objective: Measure changes in physical functioning by PF-10 questionnaire in COPD patients treated with Spiolto Respimat after ca. 6 weeks in routine clinical practice [ Time Frame: 6 weeks ]
Change History Complete list of historical versions of study NCT02719639 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 8, 2019)
  • Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2) [ Time Frame: Baseline and week 6 ]
    Change in PF-10 score was determined by taking into account the individual change of each patient between visit 1 and visit 2. The PF-10 used for assessing the primary outcome is a sub-domain of the validated Short Form (SF)-36 quality of life questionnaire and consists of 10 questions evaluating the experienced restrictions while conducting usual activities. Each question of the PF-10 may be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3, respectively. The scores will be summed up between 10 and 30. The final sum of the individual scores was standardized to a range of 0 to 100 using the formula: 100*(sum-10)/20. The lower the score the more disability. The higher the score the less disability. If less than half of the scale items were missing, missing values were replaced with the mean of the other values. If half or more than half was missing, no score was calculated.
  • General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). [ Time Frame: Baseline and week 6 ]
    This outcome measures general condition of the patient evaluated by the physician (PGE score) at visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1) evaluated on an 8-point scale with the scores "Poor (1,2)", "Satisfactory (3, 4)", "Good (5, 6)" and "Excellent (7, 8)". More the score, the better is the general condition of patient.
  • Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) [ Time Frame: Approximately 6 weeks ]
    At visit 2 patients were asked for their overall satisfaction with the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.
  • Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) [ Time Frame: Approximately 6 weeks ]
    At visit 2 patients were asked how satisfied they were with inhaling from the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.
  • Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) [ Time Frame: Approximately 6 weeks ]
    At visit 2 patients were asked how satisfied they were with handling the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.
Original Secondary Outcome Measures
 (submitted: March 21, 2016)
  • Secondary objectives: Evaluate patients' satisfaction by 7-point ordinal scale [ Time Frame: 6 weeks ]
  • Secondary objective: Evaluate patients' general condition by 8-point PGE scale [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title OTIVACTO Regional Center Vienna (RCV) Non-Interventional Study (NIS)
Official Title Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice.
Brief Summary Real-world data on the effects of a fixed-dose combination Long-acting beta agonists + long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol administered in a single device, in COPD patients who need treatment with two long-acting bronchodilators, is not available. This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto Respimat according to the approved Summary of Product Characteristics (SmPC).
Detailed Description

Purpose:

Study Design:

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population COPDS patients
Condition Pulmonary Disease, Chronic Obstructive
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 8, 2019)
7443
Original Estimated Enrollment
 (submitted: March 21, 2016)
7215
Actual Study Completion Date May 31, 2017
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

  1. Written informed consent prior to participation
  2. Female and male patients with more or equal to 40 years of age
  3. Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto Respimat Summary of Product Characteristics (SmPC) and chronic obstructive pulmonary disease (COPD) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline recommendation

Exclusion criteria:

  1. Patients with contraindications according to Spiolto Respimat SmPC
  2. Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months
  3. Patients continuing LABA- Inhalative Corticosteroids (ICS) treatment should not be additionally treated with Spiolto Respimat in order to avoid a double dosing of long-acting beta-agonists
  4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
  5. Pregnancy and lactation
  6. Patients currently listed for lung transplantation
  7. Current participation in any clinical trial or any other non-interventional study of a drug or device
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Czechia,   Hungary,   Israel,   Romania,   Russian Federation,   Slovakia,   Slovenia,   Switzerland
Removed Location Countries Bulgaria,   Czech Republic
 
Administrative Information
NCT Number NCT02719639
Other Study ID Numbers 1237.44
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date January 2019