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OpenTrials
Completed

NCT Number: NCT03663569

A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MBAL Sveti Ivan Rilski-2003, Dupnitsa, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spiolto® Respimat®

Drug

Drug

Primary outcomes

  1. Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2

    Time frame: At Visit 2 (6 weeks after baseline visit 1)

    Therapeutic success of Spiolto® Respimat® treatment was defined as 0.4 point decrease in the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire - Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Each of the 10 CCQ questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do) at baseline (Visit 1) and at the end of the observation after approximately 6 weeks (Visit 2). The sum of the scores divided by 10 gives the CCQ score, which measures the health and functional status. A higher CCQ score is indicative of worse status.

Secondary outcomes

  1. 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: At baseline visit 1 and 6 weeks thereafter at visit 2

    The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6 at baseline and at the end of observation after approximately 6 weeks. Symptom domain covered 4 questions (number 1, 2, 5, 6), Functional state domain covered 4 questions (number 7, 8, 9, 10), and Mental state domain covered 2 questions (number 3, 4). Scores for the questions in each domain were summed up and divided by the number of questions in each domain giving the resulting score for respective domain. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. Change of the score was calculated as visit 2 minus visit 1.

  2. Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)

    Time frame: At visit 1

    PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).

  3. Physician's Global Evaluation (PGE) Score at Visit 2

    Time frame: At visit 2 (6 weeks after baseline visit 1)

    PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).

  4. Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2

    Time frame: At visit 2 (6 weeks after baseline visit 1)

    Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported.

  5. Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2

    Time frame: At visit 2 (6 weeks after baseline visit 1)

    Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported

  6. Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2

    Time frame: At visit 2 (6 weeks after baseline visit 1)

    Patient satisfaction with handling of the Respimat® inhalation device at visit 2 was reported.

  7. Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2

    Time frame: At visit 2 (6 weeks after baseline visit 1)

    Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 was reported.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Changes in Clinical Control of COPD Patients Measured by the Clinical COPD Questionnaire During Therapy With Spiolto®Respimat® in Routine Clinical Practice

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2018
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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