CClinicalTrials.gg
CompletedNCT02792946Updated Jun 16, 2017

Compare the Efficacy and Safety of Surfolase CR Tablet With Surfolase Capsule in Patients With Acute Bronchitis

A Phase 3 interventional study of Acebrophylline in Acute Bronchitis, sponsored by Hyundai Pharmaceutical Co., LTD.. Completed. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-06-16.

Sponsored by Hyundai Pharmaceutical Co., LTD. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Nov 2015, registered Jun 2016).
Phase
Phase 3
Study type
Interventional
Enrollment
244
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study summary

Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients with acute bronchitis

02

Conditions studied

  • Acute Bronchitis

Browse trials for

03

In context

Bronchitis

268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.

This study's enrollment of 244 is above the median of 120 across 184 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

Hyundai Pharmaceutical Co., LTD. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female aged 19 to 65 years, inclusive
  2. Patients with acute bronchitis which is accompanied with a cough which includes sputum within 48 hours and has over 5 for Bronchitis severity score (BSS) at Screening
  3. Patients who agreed to participate clinical trial and sign on informed consent form

Exclusion criteria

Exclusion Criteria:

  1. Patients who are suspicious or diagnosed for pneumonia
  2. Patients with chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), bronchiolitis, asthma, bronchial asthma
  3. Patients with active infection who needs administration of antibiotics
  4. Patients with myocardial infarction, congestive heart failure
  5. Patients with renal disorder or liver disorder
  6. Patients with hypotension or hypertension
  7. Patients with history of epilepsy
  8. Patients with hyperthyroidism
  9. Patients with gastroduodenal ulcer
  10. Patients with sever hypoxemia
  11. Patients who are in drug or therapy or planned to have;

    • antibiotics, anti-virus, angiotensin converting enzyme (ACE) inhibitor and systemic or inhalation glucocorticosteroids: from 2 weeks prior to administration of investigational product to termination of clinical trial
    • Angiotension II receptor blocker (ARB), secretolytics/mucolytics, expectorants, antitussives, a herb medicines which has antitussive or expectorant effect: from 2 days prior to administration of investigational product to termination of clinical trial
    • Analgesics except acetaminophen, antihistamines, β2-agonists, bronchodilators which includes anticholinergic agents, xanthine derivatives, central nervous system stimulants, drug which is known for interaction between acebrophylline (cimetidine, alloprinol, oral anticoagulants, furosemide, reserpine, barbiturates, phenytoin) and symtomatic therapy for other therapy for acute bronchitis: whole period for clinical trial
  12. Smokers
  13. Patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug
  14. Patients with pregnant and/or have breast feeding.
  15. Patients with no intention to use appropriate contraceptives or has a plan to become pregnant
  16. Patients who had an administrationb of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial
  17. Patients who are identified as inappropriate by other investigators to participate clinical trial
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
244 participants (actual)

Study arms

  • Experimental
    Sulfolase CR (200mg, QD)

    for 7 days with or without meal

    Drug: Acebrophylline

  • Active comparator
    Sulfolase Capsule (100mg, BID)

    for 7 days with or without meal

    Drug: Acebrophylline

Interventions

  • DrugAcebrophylline
06

What researchers measure

Primary outcomes

  1. Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS)

    Time frame: Baseline, At Day 7

Secondary outcomes

  1. Change from Baseline in baseline to Day 7 for number of BSS per symptom

    Time frame: Baseline, At Day 7

  2. Response rate at Day 7

    Time frame: Baseline, At Day 7

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02792946
Lead sponsor
Hyundai Pharmaceutical Co., LTD.
Responsible party
Sponsor
First posted
Jun 8, 2016
Start date
Nov 2015
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Jun 16, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion