Acute Upper Respiratory Tract InfectionPhase 3NCT03827590
Clinical Trials to Assess the Efficacy and Safety of HLIM
A Phase 3 study testing Test in people with Acute Upper Respiratory Tract Infection and Acute Bronchitis, run by SamA Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to assess the efficacy and safety of HLIM Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Acute Upper Respiratory Tract Infection, Acute Bronchitis
- What is being tested?
- Test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 487 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Nov 2018to 31 Oct 2019
- Phase
- Phase 3
- 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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 2 and 75
- Weight more than 11.5 kg
Who cannot join
- Has a history of hypersensitivity to IP ingredients
- Hypertension or Diabetes
- Smoking more than 20 pack-years
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul, Guro-gu, 08308
Jaejung Shim, M.D., Ph.D, +82-2-2626-1114, jaejshim@kumc.or.kr
About this study
Official title: Phase III Clinical Trials to Assess the Efficacy and Safety of HLIM for Symptomatic Relief of Cough and Sputum in Patients With Acute Upper Respiratory Tract Infection or Acute Bronchitis
The purpose of this study is to assess the efficacy and safety of HLIM
Read the detailed description
A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.
- Being tested
- Test, Active Comparator Control 1, Active Comparator Control 2, Placebo
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestDrug
Also called HLIM+SA160021 Placebo+SA160022 Placebo
three times a day for five days
Active Comparator Control 1Drug
Also called HLIM Placebo+SA160021+SA160022 Placebo
three times a day for five days
Active Comparator Control 2Drug
Also called HLIM Placebo+SA160021 Placebo+SA160022
three times a day for five days
PlaceboDrug
Also called HLIM Placebo+SA160021 Placebo+SA160022 Placebo
three times a day for five days
| Study group | Role | What they receive |
|---|---|---|
| HLIM | Experimental | HLIM+SA160021 Placebo+SA160022 Placebo Receives: Drug: Test |
| SA160021 | Active comparator | HLIM Placebo+SA160021+SA160022 Placebo Receives: Drug: Active Comparator Control 1 |
| SA160022 | Active comparator | HLIM Placebo+SA160021 Placebo+SA160022 Receives: Drug: Active Comparator Control 2 |
| Placebo | Placebo comparator | HLIM Placebo+SA160021 Placebo+SA160022 Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo
0(absent) ~ 4(very severe), Total Score: 0~20
Measured: 5 days
Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group
0(absent) ~ 4(very severe), Total Score: 0~20
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start29 Nov 2018
- Primary completion30 May 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Upper Respiratory Tract InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 487 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SamA Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827590
- Sponsor's protocol ID
- HLIM(SA16002)
- Status last verified
- Feb 2019
- First submitted
- 10 Jan 2019
- Last updated
- 8 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trials to Assess the Efficacy and Safety of HLIM for Symptomatic Relief of Cough and Sputum in Patients With Acute Upper Respiratory Tract Infection or Acute Bronchitis
- ClinicalTrials.gov ID
- NCT03827590
- Acronym / sponsor ID
- HLIM(SA16002)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 487 participants (estimated)
- Lead sponsor
- SamA Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 1 Feb 2019 (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 assess the efficacy and safety of HLIM
Detailed description
A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HLIM | Experimental | Drug: TestHLIM+SA160021 Placebo+SA160022 Placebo |
| SA160021 | Active comparator | Drug: Active Comparator Control 1HLIM Placebo+SA160021+SA160022 Placebo |
| SA160022 | Active comparator | Drug: Active Comparator Control 2HLIM Placebo+SA160021 Placebo+SA160022 |
| Placebo | Placebo comparator | Drug: PlaceboHLIM Placebo+SA160021 Placebo+SA160022 Placebo |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 2 and 75
- Weight more than 11.5 kg
Key exclusion criteria (3 listed)
- Has a history of hypersensitivity to IP ingredients
- Hypertension or Diabetes
- Smoking more than 20 pack-years
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 |
|---|---|---|
| TestAlso: HLIM+SA160021 Placebo+SA160022 Placebothree times a day for five days | Drug | HLIM |
| Active Comparator Control 1Also: HLIM Placebo+SA160021+SA160022 Placebothree times a day for five days | Drug | SA160021 |
| Active Comparator Control 2Also: HLIM Placebo+SA160021 Placebo+SA160022three times a day for five days | Drug | SA160022 |
| PlaceboAlso: HLIM Placebo+SA160021 Placebo+SA160022 Placebothree times a day for five days | Drug | Placebo |
Primary outcome
Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo
Time frame: 5 days
0(absent) ~ 4(very severe), Total Score: 0~20
Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group
Time frame: 5 days
0(absent) ~ 4(very severe), Total Score: 0~20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Test in people with Acute Upper Respiratory Tract Infection and Acute Bronchitis, run by SamA Pharmaceutical Co., Ltd at 1 site in South Korea.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Feb 2019. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo (time frame: 5 days). The study lists 2 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 8 Feb 2019.