Acute BronchitisPhase 2NCT03309800

A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients

A Phase 2 study testing HL301 in people with Acute Bronchitis, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Placebo in acute bronchitis patients. Read more about this study

Who is it for?: Ages 19 to 80 years
Conditions the study is for: Acute Bronchitis
What is being tested?: HL301
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 168 participants
Where: 1 siteSouth Korea
Study dates: 29 Mar 2017to 28 Aug 2017
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 19 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Both gender, 19 years ≤ age ≤ 80 years
(Bronchitis Severity Score)* ≥ 5point at Visit 2 (Randomized Visit)
Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
Those who can comply with the requirements of clinical trials
Written consent voluntarily to participate in this clinical trial

Who cannot join

Patients with respiratory and systemic infections requiring systemic antibiotic therapy
Patients with bleeding tendency
Patients who investigators determines to severe respiratory disease that would interfere with study assessment
Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to Visit 2
Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Kyung Hee University Hospital
Seoul, Dongdaemun-gu, 130-872

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Placebo in acute bronchitis patients.

Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject, Total usage of Acetaminophen

Conditions: Acute Bronchitis
Being tested: HL301, HL301(Placebo)
Keywords: Acute Bronchitis
Medical subject headings: Bronchitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HL301Drug
HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
HL301(Placebo)Drug
HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

Study groups in NCT03309800
Study group	Role	What they receive
Experimental	Experimental	HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment Receives: Drug: HL301
Placebo comparator	Placebo comparator	HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment Receives: Drug: HL301(Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

Bronchitis Severity Total Score(BSS) Change
Evaluation period: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
Measured: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)

Secondary outcomes (3)

The improvement and improvement rate of the tester for the treatment response (Chi-square test or Fisher's Exact test)
Evaluation period: Visit 3 (7 day)
Measured: Visit 3 (7 day)
The satisfaction of the subject (Questionnaire)
Evaluation period: Visit 3 (7 day)
Measured: Visit 3 (7 day)
Total usage of Acetaminophen
Evaluation period: Visit 3 (7 day)
Measured: Visit 3 (7 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 201728 Aug 2017

First posted16 Oct 2017
Study start29 Mar 2017
Primary completion17 Aug 2017
Study completion28 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute BronchitisStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03309800
Sponsor's protocol ID: HL_HL301_202
Status last verified: Oct 2017
First submitted: 8 Sep 2017
Last updated: 16 Oct 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Bronchitis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients
ClinicalTrials.gov ID: NCT03309800
Acronym / sponsor ID: HL_HL301_202
Conditions: Acute Bronchitis
Keywords: Acute Bronchitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
Study start: 29 Mar 2017 (actual)
Primary completion: 17 Aug 2017 (actual)
Study completion: 28 Aug 2017 (actual)
First posted: 16 Oct 2017 (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 Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Placebo in acute bronchitis patients.

Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject, Total usage of Acetaminophen

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental	Experimental	Drug: HL301HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
Placebo comparator	Placebo comparator	Drug: HL301(Placebo)HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

Who may qualify

Ages: 19 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Both gender, 19 years ≤ age ≤ 80 years
(Bronchitis Severity Score)* ≥ 5point at Visit 2 (Randomized Visit)
Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
Those who can comply with the requirements of clinical trials
Written consent voluntarily to participate in this clinical trial

Key exclusion criteria (5 listed)

Patients with respiratory and systemic infections requiring systemic antibiotic therapy
Patients with bleeding tendency
Patients who investigators determines to severe respiratory disease that would interfere with study assessment
Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to Visit 2
Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2

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
HL301HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment	Drug	Experimental
HL301(Placebo)HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment	Drug	Placebo comparator

Primary outcome

Bronchitis Severity Total Score(BSS) Change
Time frame: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
Evaluation period: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)

3 secondary outcomes

The improvement and improvement rate of the tester for the treatment response (Chi-square test or Fisher's Exact test)
Time frame: Visit 3 (7 day)
The satisfaction of the subject (Questionnaire)
Time frame: Visit 3 (7 day)
Total usage of Acetaminophen
Time frame: Visit 3 (7 day)

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 16 Oct 2017.

Related trials for Acute Bronchitis

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Active, not recruiting
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Bronchiolitis
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis
Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction

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 2 study testing HL301 in people with Acute Bronchitis, run by Hanlim Pharm. 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 5 inclusion and 5 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 16 Oct 2017. 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 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?

Bronchitis Severity Total Score(BSS) Change (time frame: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03309800.

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 16 Oct 2017.