BronchiectasisPhase 2NCT01818544
Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis
A Phase 2 study testing BAY85-8501 in people with Bronchiectasis, run by Bayer at 33 sites in 5 countries.
Trial summary
The primary objective of this study is to assess the safety and tolerability of 28 day oral administration of BAY85-8501 versus placebo in subjects with non-CF Bronchiectasis (BE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- BAY85-8501
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 33 sitesin 5 countries
- Study dates
- Apr 2013to Jun 2014
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proven and documented diagnosis of non-CF (cystic fibrosis) idiopathic or post-infectious BE (bronchiectasis) by computed tomography (CT) scan [conventional high resolution CT is considered the standard], including 2 or more lobes and dilated airways compatible with BE at initial diagnosis
- Stable pulmonary status as indicated by the forced, expired volume in 1 second (FEV1) percent predicted ≥30% and <90% (post-bronchodilator)
- Stable (i.e., no dose change) regimen of standard BE treatment administered at least for 4 weeks prior to screening
- Cough on most days
Who cannot join
- Forced, expired volume in 1 second <30% or ≥90% predicted (post-bronchodilator)
- Recent significant hemoptysis (≥300 mL or requiring blood transfusion) in the preceding 4 weeks before screening (and during the screening period)
- Known cystic fibrosis and/or documented chronic bronchial asthma
- Active allergic bronchopulmonary aspergillosis (ABPA)
- Diagnosis of common variable immunodeficiency (CVID)
- Systemic or inhaled antibiotic treatment within 4 weeks prior to screening
- Treatment of an exacerbation within 4 weeks prior to screening
- Systemic corticosteroids at >10 mg/day prednisolone equivalent for >2 weeks within 4 weeks prior to screening
Trial locations and contacts
33 sites in 5 countries.
33 sites in 5 countries
United Kingdom12 sites
Study site
Bradford, West Yorkshire, BD9 6RJ
Study site
Cottingham, Humberside, HU16 5JQ
Study site
Dundee, Tayside, DD2 1UB
Study site
Glasgow, G42 9TY
Study site
Leicester, Leicestershire, LE3 9QP
Study site
Liverpool, Merseyside, L9 7JU
Study site
London, EC1M 6BQ
Study site
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Study site
Sheffield, South Yorkshire, S5 7AU
Study site
South Shields, Tyne and Wear, NE34 0PL
Study site
Southampton, Hampshire, SO16 6YD
Study site
Wolverhampton, West Midlands, WV10 0QP
Germany9 sites
Study site
Donaustauf, Bavaria, 93093
Study site
Großhansdorf, Schleswig-Holstein, 22927
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20354
Study site
Hanover, Lower Saxony, 30167
Study site
Jena, Thuringia, 07740
Study site
Kiel, Schleswig-Holstein, 24105
Study site
Leipzig, Saxony, 04103
Study site
Lübeck, Schleswig-Holstein, 23538
Study site
Rüdersdorf, Brandenburg, 15562
Italy6 sites
Study site
Genova, 16132
Study site
Milan, 20142
Study site
Naples, 80131
Study site
Orbassano, Torino, 10043
Study site
Padova, 35128
Study site
Siena, 53100
Spain4 sites
Study site
Badalona, Barcelona, 08916
Study site
Madrid, Madrid, 28046
Study site
Majadahonda, Madrid, 28222
Study site
Salt, Girona, 17190
About this study
Official title: A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY85-8501 in Patients With Non-Cystic Fibrosis Bronchiectasis
The primary objective of this study is to assess the safety and tolerability of 28 day oral administration of BAY85-8501 versus placebo in subjects with non-CF Bronchiectasis (BE).
The secondary objectives are to examine the effect of BAY85-8501 on pulmonary function, biomarkers of inflammation and tissue damage, and the impact on overall health and perceived well-being and to evaluate the pharmacokinetics of BAY85-8501.
- Conditions
- Bronchiectasis
- Being tested
- BAY85-8501, Placebo
- Keywords
- Elastase Inhibition
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY85-8501Drug
BAY85-8501 (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning
PlaceboDrug
Placebo (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| BAY85-8501 | Experimental | Not described Receives: Drug: BAY85-8501 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of Subjects Who Need To Discontinue Study Medication Due To Findings In Physical Examination
Measured: From start of study treatment up to follow up visit (28 days after last dose)
Change From Baseline in Systolic Blood Pressure At Days 7, 14, 21, 28, 56
Measured: Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Diastolic Blood Pressure At Days 7, 14, 21, 28, 56
Measured: Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Heart Rate At Days 7, 14, 21, 28, 56
Measured: Baseline (Day 1), Day 7, 14, 21, 28, 56
Number of Subjects With new Abnormal (Pathologic) Electrocardiogram (ECG) Findings From Baseline to Day 28
Measured: Baseline (Day 1), Day 7, 14, 21, 28
Number of Subjects who Show Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TB) Abnormalities in Their Safety Lab Assessment
Measured: Baseline (Day 1), Day 7, 14, 21, 28, 56
Number of Subjects With Drug Related Adverse Events as a Measure of Safety And Tolerability
Measured: Baseline (Day 1), Day 7, 14, 21, 28, 56
Secondary outcomes (15)
Change From Baseline in Pulmonary Function Test Forced Expired Volume in 1 Second (FEV1) At Days 7, 14, 21, 28, 56
Measured: Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Pulmonary Function Test Forced Vital Capacity (FVC) at Days 7, 14, 21, 28, 56
Measured: Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Pulmonary Function Test Forced Expiratory Flow Over the Middle Half of Subject's Forced Vital Capacity (FVC) (FEF2575) at Days 7, 14, 21, 28, 56
Measured: Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Total Score on St. George's Respiratory Questionnaire (SGRQ) at Day 28 and 56
Measured: Baseline (Day 1), Day 28 and 56
Change From Baseline in 24 Hours Sputum Weight at Day 28
Measured: Baseline (Day 1), Day 28
Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Alpha1 Antitrypsin Human Neutrophil Elastase (A1AHNE) Complex, Interleukin-8(IL-8)
Measured: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Neutrophil cell Count
Measured: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Human Neutrophil Elastase (NE) Activity in Sputum at Days 14, 28, 56
Measured: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Human Neutrophil Elastase (NE) Concentration in Sputum at Days 14, 28, 56
Measured: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: C-reactive Protein
Measured: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Interleukin-8 (IL8)
Measured: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Neutrophil cell Count
Measured: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Urine At Days 14, 28, 56: Creatinine
Measured: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Desmosine
Measured: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Normalized Desmosine Value to Creatinine
Measured: Baseline (Day 1), Day 14, 28 and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818544
- Sponsor's protocol ID
- 16359
- Other IDs
- 2012-004491-18
- Status last verified
- Jul 2015
- First submitted
- 8 Mar 2013
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY85-8501 in Patients With Non-Cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT01818544
- Acronym / sponsor ID
- 16359
- Conditions
- Bronchiectasis
- Keywords
- Elastase Inhibition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Mar 2013 (estimated)
- 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 primary objective of this study is to assess the safety and tolerability of 28 day oral administration of BAY85-8501 versus placebo in subjects with non-CF Bronchiectasis (BE).
The secondary objectives are to examine the effect of BAY85-8501 on pulmonary function, biomarkers of inflammation and tissue damage, and the impact on overall health and perceived well-being and to evaluate the pharmacokinetics of BAY85-8501.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY85-8501 | Experimental | Drug: BAY85-8501 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Proven and documented diagnosis of non-CF (cystic fibrosis) idiopathic or post-infectious BE (bronchiectasis) by computed tomography (CT) scan [conventional high resolution CT is considered the standard], including 2 or more lobes and dilated airways compatible with BE at initial diagnosis
- Stable pulmonary status as indicated by the forced, expired volume in 1 second (FEV1) percent predicted ≥30% and <90% (post-bronchodilator)
- Stable (i.e., no dose change) regimen of standard BE treatment administered at least for 4 weeks prior to screening
- Cough on most days
Key exclusion criteria (8 listed)
- Forced, expired volume in 1 second <30% or ≥90% predicted (post-bronchodilator)
- Recent significant hemoptysis (≥300 mL or requiring blood transfusion) in the preceding 4 weeks before screening (and during the screening period)
- Known cystic fibrosis and/or documented chronic bronchial asthma
- Active allergic bronchopulmonary aspergillosis (ABPA)
- Diagnosis of common variable immunodeficiency (CVID)
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 |
|---|---|---|
| BAY85-8501BAY85-8501 (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning | Drug | BAY85-8501 |
| PlaceboPlacebo (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning | Drug | Placebo |
Primary outcome
Number Of Subjects Who Need To Discontinue Study Medication Due To Findings In Physical Examination
Time frame: From start of study treatment up to follow up visit (28 days after last dose)
Change From Baseline in Systolic Blood Pressure At Days 7, 14, 21, 28, 56
Time frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Diastolic Blood Pressure At Days 7, 14, 21, 28, 56
Time frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Heart Rate At Days 7, 14, 21, 28, 56
Time frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
Number of Subjects With new Abnormal (Pathologic) Electrocardiogram (ECG) Findings From Baseline to Day 28
Time frame: Baseline (Day 1), Day 7, 14, 21, 28
Number of Subjects who Show Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TB) Abnormalities in Their Safety Lab Assessment
Time frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
Number of Subjects With Drug Related Adverse Events as a Measure of Safety And Tolerability
Time frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
15 secondary outcomes
Change From Baseline in Pulmonary Function Test Forced Expired Volume in 1 Second (FEV1) At Days 7, 14, 21, 28, 56
Time frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Pulmonary Function Test Forced Vital Capacity (FVC) at Days 7, 14, 21, 28, 56
Time frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Pulmonary Function Test Forced Expiratory Flow Over the Middle Half of Subject's Forced Vital Capacity (FVC) (FEF2575) at Days 7, 14, 21, 28, 56
Time frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Total Score on St. George's Respiratory Questionnaire (SGRQ) at Day 28 and 56
Time frame: Baseline (Day 1), Day 28 and 56
Change From Baseline in 24 Hours Sputum Weight at Day 28
Time frame: Baseline (Day 1), Day 28
Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Alpha1 Antitrypsin Human Neutrophil Elastase (A1AHNE) Complex, Interleukin-8(IL-8)
Time frame: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Neutrophil cell Count
Time frame: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Human Neutrophil Elastase (NE) Activity in Sputum at Days 14, 28, 56
Time frame: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Human Neutrophil Elastase (NE) Concentration in Sputum at Days 14, 28, 56
Time frame: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: C-reactive Protein
Time frame: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Interleukin-8 (IL8)
Time frame: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Neutrophil cell Count
Time frame: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Urine At Days 14, 28, 56: Creatinine
Time frame: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Desmosine
Time frame: Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Normalized Desmosine Value to Creatinine
Time frame: Baseline (Day 1), Day 14, 28 and 56
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 9 Jul 2015.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
Related trials for Bronchiectasis
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingPhase 1
Phase 1 Study to Assess the Effects of HSK31858 on the QT/QTc Interval in Healthy Chinese Participants
Non-cystic Fibrosis Bronchiectasis (NCFBE)
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.
Bayer Study Director study director
Bayer
33 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY85-8501 in people with Bronchiectasis, run by Bayer at 33 sites in 5 countries.
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 4 inclusion and 8 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 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United Kingdom, Germany, Italy, Spain, France. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number Of Subjects Who Need To Discontinue Study Medication Due To Findings In Physical Examination (time frame: From start of study treatment up to follow up visit (28 days after last dose)). The study lists 7 primary outcomes in all. 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 9 Jul 2015; AzTrials last refreshed its copy on 8 Nov 2026.