Chronic Obstructive Pulmonary DiseasePhase 1NCT03646864
A Study to Evaluate the Effects of ACT-541468 on Respiration in Patients With Moderate Chronic Obstructive Pulmonary Disease
A Phase 1 study testing ACT-541468 in people with Chronic Obstructive Pulmonary Disease, run by Idorsia Pharmaceuticals Ltd. at 5 sites in Germany.
Trial summary
A study to evaluate the effects of ACT-541468 on respiration in patients with moderate chronic obstructive pulmonary disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- ACT-541468
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 5 sitesGermany
- Study dates
- 15 Nov 2018to 19 Sep 2019
- Phase
- Phase 1
- 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
- Signed informed consent prior to any study-mandated procedure
- Male and female subjects aged ≥ 18 years
- Body mass index of 18.0 to 35.0 kg/m2
- Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Screening Visit 2 and on Day 1 pre-dose of the first period. They must consistently and correctly use a reliable method of contraception with a failure rate of < 1% per year, be sexually inactive, or have a vasectomized partner.
- Women of non-childbearing potential, i.e., postmenopausal
- Diagnosis of moderate COPD documented by medical history (including risk factors and familial history) and confirmed by the assessment of dyspnea using the Modified British Medical Research Council (mMRC) questionnaire, the COPD assessment test (CATTM), and the post bronchodilator pulmonary function tests which should meet the modified Global Initiative for Obstructive Lung Disease (GOLD) criterion for moderate obstruction severity:
- Moderate COPD: Forced expiratory volume in 1 sec (FEV1) / Forced vital capacity (FVC) ratio ≤ 70% and 40% ≤ FEV1 < 80% of predicted
- Subjects with 0 to 1 (not leading to hospital admission) exacerbation in the last year (i.e., who belong to Group A and B of the GOLD classification)
Who cannot join
- Pregnant or lactating women
- History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment
- Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results such as history of non-compliance to medical regimen, psychiatric disease, neurological disorders which may impact sleep, motor performance, or cognition
- Need for continuous oxygen therapy or non invasive ventilation that would interfere with the study evaluation (e.g., required during the night), as per investigator judgement
- Subjects with clinically significant abnormality on the screening night PSG as per investigator judgement, including evidence of Periodic limb movement disorder with arousal index ≥ 15/h, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, parasomnia including nightmare disorder, sleep terror disorder, and/or sleepwalking disorder but excluding any COPD-related abnormalities
- Emergency treatment with antibiotics or systemic corticosteroids or any hospitalization due to COPD within 2 months prior to Screening
- SaO2 < 90% during wakefulness and/or SaO2 < 85% for > 5 consecutive min during the screening night PSG
- AHI > 10 within the last 3 months prior to Screening, or at the polygraphy (PG) assessed after Screening visit 1 and before Screening visit 2 (if no previous data available only) or on the screening night PSG (only for subjects having AHI<10 at Screening visit 1 or after PG)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Advanced Sleep Research
Berlin, 10117
Klinische Forschungsgruppe Nord
Dresden, 01069
Klinische Forschungsgruppe Nord
Hanover, 30159
framol-med GmbH, Lungenpraxis
Rheinau, 48431
ZMS
Warendorf, 48231
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Moderate Chronic Obstructive Pulmonary Disease
A study to evaluate the effects of ACT-541468 on respiration in patients with moderate chronic obstructive pulmonary disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- ACT-541468, Placebo
- 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.
ACT-541468Drug
ACT-541468 will be orally administered as a tablet (50 mg strength) at a once daily (o.d.) dose of 50 mg in the evening.
PlaceboOther
Placebo will be orally administered as a tablet matching ACT-541468, o.d. in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | ACT-541468 50 mg from Day 1 to Day 5 of Period A Receives: Drug: ACT-541468 |
| Treatment B | Placebo comparator | Placebo from Day 1 to Day 5 of Period B Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean SaO2 during total sleep time (TST) after multiple-dose administration (i.e., at Night 5) as measured by finger pulse oximetry and PSG
Measured: Duration: for up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start15 Nov 2018
- Primary completion19 Sep 2019
- Study completion19 Sep 2019
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2-way crossover study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646864
- Sponsor's protocol ID
- ID-078-109
- Other IDs
- 2018-001828-19, 2018
- Status last verified
- Sep 2019
- First submitted
- 23 Aug 2018
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Moderate Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03646864
- Acronym / sponsor ID
- ID-078-109
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 24 Aug 2018 (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.
A study to evaluate the effects of ACT-541468 on respiration in patients with moderate chronic obstructive pulmonary disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-way crossover study
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: ACT-541468ACT-541468 50 mg from Day 1 to Day 5 of Period A |
| Treatment B | Placebo comparator | Other: PlaceboPlacebo from Day 1 to Day 5 of Period B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent prior to any study-mandated procedure
- Male and female subjects aged ≥ 18 years
- Body mass index of 18.0 to 35.0 kg/m2
- Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Screening Visit 2 and on Day 1 pre-dose of the first period. They must consistently and correctly use a reliable method of contraception with a failure rate of < 1% per year, be sexually inactive, or have a vasectomized partner.
- Women of non-childbearing potential, i.e., postmenopausal
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment
- Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results such as history of non-compliance to medical regimen, psychiatric disease, neurological disorders which may impact sleep, motor performance, or cognition
- Need for continuous oxygen therapy or non invasive ventilation that would interfere with the study evaluation (e.g., required during the night), as per investigator judgement
- Subjects with clinically significant abnormality on the screening night PSG as per investigator judgement, including evidence of Periodic limb movement disorder with arousal index ≥ 15/h, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, parasomnia including nightmare disorder, sleep terror disorder, and/or sleepwalking disorder but excluding any COPD-related abnormalities
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 |
|---|---|---|
| ACT-541468ACT-541468 will be orally administered as a tablet (50 mg strength) at a once daily (o.d.) dose of 50 mg in the evening. | Drug | Treatment A |
| PlaceboPlacebo will be orally administered as a tablet matching ACT-541468, o.d. in the evening. | Other | Treatment B |
Primary outcome
Mean SaO2 during total sleep time (TST) after multiple-dose administration (i.e., at Night 5) as measured by finger pulse oximetry and PSG
Time frame: Duration: for up to 8 hours
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 23 Sep 2019.
- 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.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACT-541468 in people with Chronic Obstructive Pulmonary Disease, run by Idorsia Pharmaceuticals Ltd. at 5 sites 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 8 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 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Mean SaO2 during total sleep time (TST) after multiple-dose administration (i.e., at Night 5) as measured by finger pulse oximetry and PSG (time frame: Duration: for up to 8 hours). 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 23 Sep 2019; AzTrials last refreshed its copy on 2 Nov 2026.