Chronic Obstructive Pulmonary DiseasePhase 4NCT04231214
Effects of Spiolto® Respimat® (Tiotropium/Olodaterol) on Cardiac Function in Hyperinflated COPD Subjects
A Phase 4 study testing Olodaterol-Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
The purpose of this study is to examine the effect of a combined LABA/LAMA treatment with olodaterol/tiotropium on small airway function, autonomic nervous system and cardiac function in COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Olodaterol-Tiotropium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jan 2020to 18 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to give written informed consent.
- Male and female subjects, aged ≥ 40 years. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Subjects with stable COPD according to the current GOLD guidelines (GOLD 2018).
- Subjects with airflow limitation indicated by a post-bronchodilator FEV1 <80% of the predicted normal value and a post-bronchodilator FEV1/FC<0.7 at Visit 1. Post-bronchodilator refers to within 10-15 min after inhalation of 400 µg (4x100 µg) of salbutamol.
- Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
- Hyperinflated subjects with RVol>135% predicted as measured at Visit 1, before intake of salbutamol.
Who cannot join
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, lung function or ECG at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease (including but not confined to aneurysm, hypokalemia, decompensated heart failure or hypertrophic obstructive cardiomyopathy), malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease (including but not confined to thyrotoxicosis) or pulmonary disease other than COPD (including but not confined to tuberculosis, bronchiectasis, cystic fibrosis, pulmonary hypertension, sarcoidosis, interstitial lung disease or lung fibrosis).
- Use of other investigational drug (approved or unapproved) at the time of enrolment, or within 30 days or 5 half-lives prior to Visit 1, whichever is longer.
- History of drug or alcohol abuse.
- Risk of non-compliance with study procedures.
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
Show all 32Show fewer
- History of an acute respiratory infection four weeks prior to Visit 1 and between Visit 1 and 3. These patients will not be eligible, but will be permitted to rescreened 4 weeks after the resolution of the respiratory tract infection.
- Subjects with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof:
- anticholinergics
- long and short acting beta-2 agonists
- sympathomimetic amines
- Subjects with a history of long QT syndrome or whose QTcF (Fridericia method) measured at Visit 1 is prolonged (>450 ms for males and >470 ms for females). These subjects should not be re-screened.
- Subjects who have clinically significant cardiovascular abnormalities, which could interfere with the assessment of the study treatment (such as but not limited to cardiac arrhythmias, heart failure with left ventricular ejection fraction < 40 % as determined by MRI scan at Visit 2, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, history of myocardial infarction 6 months prior to Visit 1 or uncontrolled hypertension)
- Subjects with a known history or current atrial fibrillation to be confirmed by ECG at Visit 1.
- Subjects with pacemaker or bypass.
- Subjects with extensive tattoos.
- Subjects with a mean sitting systolic blood pressure >160 mmHg and/or mean sitting diastolic blood pressure > 90 mmHg at Visit 1. These subjects will be permitted to be re-screened after initiation or intensification of an antihypertensive therapy and achieving a controlled disease status.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Subjects with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or severe renal impairment (GFR ≤ 50 mL/min/1.73 m2) including those with end-stage renal disease requiring dialysis or urinary retention. Benign Prostatic Hyperplasia (BPH) subjects who are stable on treatment can be considered.
- Subjects with insulin-dependent diabetes mellitus.
- Clinically evident polyneuropathy.
- Subjects with active/ clinical history of asthma.
- Subjects unable to undergo MRI scans, including claustrophobia or presence of any metal objects within the patient, preventing from MRI scan (e.g. pacemaker, aneurysm clips).
- History of one COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization within 3 months prior to Visit 1, to 3. Subjects may be re-screened after a minimum of 3 months after the resolution of the COPD exacerbation.
- More than one COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization within one year before Visit 1.
- Subjects requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
- Subjects with pulmonary lobectomy or lung volume reduction surgery or lung transplantation.
- Subjects with a pre-existing diagnosis of alpha-1 antitrypsin deficiency or an alpha-1 antitrypsin blood level below the normal range on Visit 1.
- Subjects with a body mass index (BMI) of more than 35 kg/m2.
- Subjects participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study.
- Subjects receiving any medications in the classes listed in Table 8-1 and Table 8-2.
- Subjects receiving medications in the classes listed in Table 8-3 should be excluded unless the medication has been stable for the specified period and the stated conditions have been met.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute and Two-week Effects of Spiolto® Respimat® (Tiotropium/Olodaterol) on Cardiac Function, the Autonomic Nervous System and Small Airway Function in Hyperinflated COPD Subjects
The purpose of this study is to examine the effect of a combined LABA/LAMA treatment with olodaterol/tiotropium on small airway function, autonomic nervous system and cardiac function in COPD. The main objective is to study the acute effect of dual bronchodilation with olodaterol/tiotropium on cardiac function measured by MRI. This work is unique as it assesses the effects of Spiolto® Respimat® on the left-ventricular end-diastolic volume and muscle sympathetic nerve activity, two endpoints relevant for cardiovascular disease. Furthermore, the study concept introduces exhaled particle analysis as a measure for small airway function, thus offering the opportunity for a mechanistic link between airway openness, hyperinflation, and cardiac function.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Olodaterol-Tiotropium
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olodaterol-TiotropiumDrug
5µg Olodaterol and 5 µg Tiotropium via the soft mist inhaler Respimat®, administered once on Day 1 or Day 9 and daily from Day 10 to Day 24
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1 | Experimental | Spiolto® Respimat® on Day 1 0.9% nebulized saline on Day 9 Spiolto® Respimat® from Day 10 to Day 24 Receives: Drug: Olodaterol-Tiotropium |
| Treatment sequence 2 | Experimental | 0.9% nebulized saline on Day 1 Spiolto® Respimat® on Day 9 Spiolto® Respimat® from Day 10 to Day 24 Receives: Drug: Olodaterol-Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in left ventricular enddiastolic volume index (LVEDVi) after single dose of Spiolto® Respimat® versus nebulized saline
Left ventricular enddiastolic volume index (LVEDVi) is a measurement of the volume of blood in the heart's left ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI
Measured: Day -8 (baseline), Day 1, Day 9, Day 24
Secondary outcomes (15)
Channge from baseline in left ventricular enddiastolic volume index (LVEDVi) multiple doses of Spiolto® Respimat® versus nebulized saline
Left ventricular enddiastolic volume index (LVEDVi) is a measurement of the volume of blood in the heart's left ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI. LVEDVi after multiple doses will be compared with LVEDVi after single dose and baseline.
Measured: Day 24
Muscle sympathetic nerve activity (MSNA) evaluated by microneurography as bursts/ 100 heart beats after single dose administration of Spiolto® Respimat® versus nebulized saline
Muscle sympathetic nerve activity (MSNA) is a measurement of the sympathetic tone and will be recorded from the peroneal nerve
Measured: Day 1, Day 9
Forced Expiratory Volume in one second expressed as percent of Vital Capacity [FEV1/VC%] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
FEV1/VC% will be measured by spirometry according to the recommendations of the American Thoracic Society and the European Respiratory Society from 2005
Measured: Day -28, Day -8, Day 1, Day 9, Day 24
Mid Forced Expiratory Flow 25/75 [MFEF 25/75, L/s] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
MFEF 25/75 will be measured by spirometry according to the recommendations of the American Thoracic Society and the European Respiratory Society from 2005
Measured: Day -28, Day -8, Day 1, Day 9, Day 24
Peak Expiratory Flow 50 [PEF, L/s] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
´PEF will be measured by spirometry according to the recommendations of the American Thoracic Society and the European Respiratory Society from 2005
Measured: Day -28, Day -8, Day 1, Day 9, Day 24
Forced Expiratory Flow 50 [FEF 50, L/s] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
FEF 50 will be measured by spirometry according to the recommendations of the American Thoracic Society and the European Respiratory Society from 2005
Measured: Day -28, Day -8, Day 1, Day 9, Day 24
Forced Expiratory Flow 25 [FEF 25, L/s] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
FEF 25 will be measured by spirometry according to the recommendations of the American Thoracic Society and the European Respiratory Society from 2005
Measured: Day -28, Day -8, Day 1, Day 9, Day 24
Residual volume expressed as percent of Total Lung Capacity [RV/TLC%] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
RV/TLC% will be measured by bodyplethysmography according to the recommendations of the American Thoracic Society and the European Respiratory Society from 2005
Measured: Day -28, Day -8, Day 1, Day 9, Day 24
Forced Vital Capacity [FVC, volume] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
FVC will be measured by spirometry according to the recommendations of the American Thoracic Society and the European Respiratory Society from 2005
Measured: Day -28, Day -8, Day 1, Day 9, Day 24
Inspiratory Capacity [IC, volume] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
IC will be measured by bodyplethysmography according to the recommendations of the American Thoracic Society and the European Respiratory Society from 2005
Measured: Day -28, Day -8, Day 1, Day 9, Day 24
Total Lung Capacity [TLC, volume] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
TLC will be measured by bodyplethysmography according to the recommendations of the American Thoracic Society and the European Respiratory Society from 2005
Measured: Day -28, Day -8, Day 1, Day 9, Day 24
Specific Airway Resistance [sRaw, kPa*s] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
sRaw will be measured by bodyplethysmography according to the recommendations of the American Thoracic Society and the European Respiratory Society from 2005
Measured: Day -28, Day -8, Day 1, Day 9, Day 24
Functional Residual Capacity [FRC, volume] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
FRC will be measured by bodyplethysmography according to the recommendations of the American Thoracic Society and the European Respiratory Society from 2005
Measured: Day -28, Day -8, Day 1, Day 9, Day 24
Slow Vital Capacity [SVC, volume] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
SVC will be measured by bodyplethysmography according to the recommendations of the American Thoracic Society and the European Respiratory Society from 2005
Measured: Day -28, Day -8, Day 1, Day 9, Day 24
Exhaled particle numbers per volume at baseline, after single dose and multiple dose of Spiolto® Respimat® versus nebulized saline.
Exhaled particles will be collected using the particle collector device PExA by PExA AB, Göteborg, Sweden. A single breath aerosol analysis will be performed with a LASAIR particle counter.
Measured: Day -8, Day 1, Day 9, Day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start28 Jan 2020
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Spiolto® Respimat® or nebulized 0.9 % saline on Day 1 and Day 9, followed by two weeks open label self-administration of Spiolto® Respimat®
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231214
- Sponsor's protocol ID
- 19-01 SPIOMI
- Status last verified
- Apr 2023
- First submitted
- 9 Jan 2020
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Two-week Effects of Spiolto® Respimat® (Tiotropium/Olodaterol) on Cardiac Function, the Autonomic Nervous System and Small Airway Function in Hyperinflated COPD Subjects
- ClinicalTrials.gov ID
- NCT04231214
- Acronym / sponsor ID
- 19-01 SPIOMI
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of a combined LABA/LAMA treatment with olodaterol/tiotropium on small airway function, autonomic nervous system and cardiac function in COPD. The main objective is to study the acute effect of dual bronchodilation with olodaterol/tiotropium on cardiac function measured by MRI. This work is unique as it assesses the effects of Spiolto® Respimat® on the left-ventricular end-diastolic volume and muscle sympathetic nerve activity, two endpoints relevant for cardiovascular disease. Furthermore, the study concept introduces exhaled particle analysis as a measure for small airway function, thus offering the opportunity for a mechanistic link between airway openness, hyperinflation, and cardiac function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Spiolto® Respimat® or nebulized 0.9 % saline on Day 1 and Day 9, followed by two weeks open label self-administration of Spiolto® Respimat®
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1 | Experimental | Drug: Olodaterol-TiotropiumSpiolto® Respimat® on Day 1 0.9% nebulized saline on Day 9 Spiolto® Respimat® from Day 10 to Day 24 |
| Treatment sequence 2 | Experimental | Drug: Olodaterol-Tiotropium0.9% nebulized saline on Day 1 Spiolto® Respimat® on Day 9 Spiolto® Respimat® from Day 10 to Day 24 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able and willing to give written informed consent.
- Male and female subjects, aged ≥ 40 years. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Subjects with stable COPD according to the current GOLD guidelines (GOLD 2018).
- Subjects with airflow limitation indicated by a post-bronchodilator FEV1 <80% of the predicted normal value and a post-bronchodilator FEV1/FC<0.7 at Visit 1. Post-bronchodilator refers to within 10-15 min after inhalation of 400 µg (4x100 µg) of salbutamol.
- Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
Key exclusion criteria (32 listed)
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, lung function or ECG at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease (including but not confined to aneurysm, hypokalemia, decompensated heart failure or hypertrophic obstructive cardiomyopathy), malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease (including but not confined to thyrotoxicosis) or pulmonary disease other than COPD (including but not confined to tuberculosis, bronchiectasis, cystic fibrosis, pulmonary hypertension, sarcoidosis, interstitial lung disease or lung fibrosis).
- Use of other investigational drug (approved or unapproved) at the time of enrolment, or within 30 days or 5 half-lives prior to Visit 1, whichever is longer.
- History of drug or alcohol abuse.
- Risk of non-compliance with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olodaterol-Tiotropium5µg Olodaterol and 5 µg Tiotropium via the soft mist inhaler Respimat®, administered once on Day 1 or Day 9 and daily from Day 10 to Day 24 | Drug | Treatment sequence 1, Treatment sequence 2 |
Primary outcome
Change from baseline in left ventricular enddiastolic volume index (LVEDVi) after single dose of Spiolto® Respimat® versus nebulized saline
Time frame: Day -8 (baseline), Day 1, Day 9, Day 24
Left ventricular enddiastolic volume index (LVEDVi) is a measurement of the volume of blood in the heart's left ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI
15 secondary outcomes
Channge from baseline in left ventricular enddiastolic volume index (LVEDVi) multiple doses of Spiolto® Respimat® versus nebulized saline
Time frame: Day 24
Muscle sympathetic nerve activity (MSNA) evaluated by microneurography as bursts/ 100 heart beats after single dose administration of Spiolto® Respimat® versus nebulized saline
Time frame: Day 1, Day 9
Forced Expiratory Volume in one second expressed as percent of Vital Capacity [FEV1/VC%] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
Time frame: Day -28, Day -8, Day 1, Day 9, Day 24
Mid Forced Expiratory Flow 25/75 [MFEF 25/75, L/s] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
Time frame: Day -28, Day -8, Day 1, Day 9, Day 24
Peak Expiratory Flow 50 [PEF, L/s] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
Time frame: Day -28, Day -8, Day 1, Day 9, Day 24
Forced Expiratory Flow 50 [FEF 50, L/s] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
Time frame: Day -28, Day -8, Day 1, Day 9, Day 24
Forced Expiratory Flow 25 [FEF 25, L/s] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
Time frame: Day -28, Day -8, Day 1, Day 9, Day 24
Residual volume expressed as percent of Total Lung Capacity [RV/TLC%] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
Time frame: Day -28, Day -8, Day 1, Day 9, Day 24
Forced Vital Capacity [FVC, volume] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
Time frame: Day -28, Day -8, Day 1, Day 9, Day 24
Inspiratory Capacity [IC, volume] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
Time frame: Day -28, Day -8, Day 1, Day 9, Day 24
Total Lung Capacity [TLC, volume] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
Time frame: Day -28, Day -8, Day 1, Day 9, Day 24
Specific Airway Resistance [sRaw, kPa*s] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
Time frame: Day -28, Day -8, Day 1, Day 9, Day 24
Functional Residual Capacity [FRC, volume] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
Time frame: Day -28, Day -8, Day 1, Day 9, Day 24
Slow Vital Capacity [SVC, volume] at baseline, after single dose and multiple of Spiolto® Respimat® versus nebulized saline.
Time frame: Day -28, Day -8, Day 1, Day 9, Day 24
Exhaled particle numbers per volume at baseline, after single dose and multiple dose of Spiolto® Respimat® versus nebulized saline.
Time frame: Day -8, Day 1, Day 9, Day 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olodaterol-Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in left ventricular enddiastolic volume index (LVEDVi) after single dose of Spiolto® Respimat® versus nebulized saline (time frame: Day -8 (baseline), Day 1, Day 9, Day 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.