Acute Upper Respiratory Tract InfectionsPhase 3NCT01151202
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup"
A Phase 3 study testing AG NPP709syrup in people with Acute Upper Respiratory Tract Infections and Bronchitis, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 6 sites in South Korea.
Trial summary
The purpose of this study is to assess therapeutic confirmation of AG NPP709 syrup to evaluate the safety and efficacy in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis. Read more about this study
- Who is it for?
- Ages 24 months to 75 years
- Conditions the study is for
- Acute Upper Respiratory Tract Infections, Bronchitis
- What is being tested?
- AG NPP709syrup
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Feb 2010to Jun 2010
- 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 24 months to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent s or patient who decided to participate in this clinical trial at his (her) own will and agreed in written letter of consent
- Patient ages between 24months and 75years
- Patient with a clinical diagnosis of acute upper respiratory tract infection or chronic inflammatory bronchitis should has any combination of at least two of following symptoms including sputum: cough, sputum, dyspnea and chest pain when breathing
- Females of child-bearing age should have nagative pregnancy test or have sufficient contraceptive protection
Who cannot join
- Patient whose the following severe respiratory disease: pneumonia, uncontrolled asthma, pancreatic fibrosis viral influenza, tuberculosis
- Patient whose the following disease: malignant tumors, severe central nervous system disorders, medication needed severe metabolic disorders
- Patient whose fructose intolerance
- Patient who has hypersensitivity anamnesis of Prospan syrup
- Patient whose heart function is abnormal: cardiac insufficiency, including the case of showing abnormal EKG test value that is clinically significant
- Patient whose liver or kidney function is serious abnormal: including the cases of ALT, AST, bilirubin and blood creatinine value exceeding three times of their upper limit, severe liver disorders, chronic kidney disease
Show all 9Show fewer
- Patient who has uncontrolled diabetes or uncontrolled hypertensions
- Patient who has experience to have participated in other clinical trial within two months before starting the trial
- Pregnant women, lactating women
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Inha University Hospital, Department of Pediatrics
Incheon
Ewha Womens University Medical Center Mokdong Hospital, Department of Allergology
Seoul
Hanyang University Medical Center, Department of Respiratory Medicine
Seoul
Konkuk University Medical Center, Department of Respiratory Medicine
Seoul
Kyung Hee University International Medical Service, Department of Pediatrics
Seoul
Kyung Hee University Medical Center, Department of Pediatrics,
Seoul
About this study
Official title: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup" in Acute Upper Respiratory Tract Infection and Chronic Inflammatory Bronchitis Patients: Double Blinded, Randomized, Active Drug Comparative, Parallel Designed, Multi-centered, Phase III Study
The purpose of this study is to assess therapeutic confirmation of AG NPP709 syrup to evaluate the safety and efficacy in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis.
- Being tested
- AG NPP709syrup
- Keywords
- acute upper respiratory tract infection, chronic inflamatory bronchitis
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG NPP709syrupDrug
| Study group | Role | What they receive |
|---|---|---|
| AG NPP709 syrup | Experimental | AG NPP709 contains Ivy leaf extract and coptis rhizoma extract Receives: Drug: AG NPP709syrup |
| Ivy leaf extract syrup | Active comparator | Not described Receives: Drug: AG NPP709syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement by global assessment
At closing visit, researcher assess clinical efficacy using the following five criteria (4: cure, 3: significant improvement, 2: improvement, 1: some improvement, 0: non-improvement or worsening of symptoms). Upper the Grade 3 outcomes are defined as "clinical success".
Measured: 5 days
Secondary outcomes (1)
determine safety by unwanted reaction, clinical laboratory test and physical examination
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 posted28 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Upper Respiratory Tract InfectionsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyunghee University Medical Center, Inha University Hospital, Ewha Womans University, Hanyang University, Konkuk University Medical Center
- Investigators
- Young-ho Na, PhD, MD, Study director, Kyung Hee University Medical Center, Department of Pediatrics,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151202
- Sponsor's protocol ID
- AG NPP_P3
- Status last verified
- Oct 2010
- First submitted
- 23 Jun 2010
- Last updated
- 5 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cho YJ, Yoon HJ, Lim DH, Yoo KH, Choi SH, Rha YH. Randomized, Double-Blind, Multicenter, Phase 3 Study of AG NPP709 Compared With Ivy Leaf Extract in Patients With Acute or Chronic Respiratory Symptoms. J Korean Med Sci. 2026 Mar 9;41(9):e97. doi: 10.3346/jkms.2026.41.e97.
PubMed 41807028
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup" in Acute Upper Respiratory Tract Infection and Chronic Inflammatory Bronchitis Patients: Double Blinded, Randomized, Active Drug Comparative, Parallel Designed, Multi-centered, Phase III Study
- ClinicalTrials.gov ID
- NCT01151202
- Acronym / sponsor ID
- AG NPP_P3
- Keywords
- acute upper respiratory tract infection, chronic inflamatory bronchitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Kyunghee University Medical Center, Inha University Hospital, Ewha Womans University, Hanyang University, Konkuk University Medical Center
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 Jun 2010 (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 purpose of this study is to assess therapeutic confirmation of AG NPP709 syrup to evaluate the safety and efficacy in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AG NPP709 syrup | Experimental | Drug: AG NPP709syrupAG NPP709 contains Ivy leaf extract and coptis rhizoma extract |
| Ivy leaf extract syrup | Active comparator | Drug: AG NPP709syrup |
Who may qualify
- Ages
- 24 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Parent s or patient who decided to participate in this clinical trial at his (her) own will and agreed in written letter of consent
- Patient ages between 24months and 75years
- Patient with a clinical diagnosis of acute upper respiratory tract infection or chronic inflammatory bronchitis should has any combination of at least two of following symptoms including sputum: cough, sputum, dyspnea and chest pain when breathing
- Females of child-bearing age should have nagative pregnancy test or have sufficient contraceptive protection
Key exclusion criteria (9 listed)
- Patient whose the following severe respiratory disease: pneumonia, uncontrolled asthma, pancreatic fibrosis viral influenza, tuberculosis
- Patient whose the following disease: malignant tumors, severe central nervous system disorders, medication needed severe metabolic disorders
- Patient whose fructose intolerance
- Patient who has hypersensitivity anamnesis of Prospan syrup
- Patient whose heart function is abnormal: cardiac insufficiency, including the case of showing abnormal EKG test value that is clinically significant
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 |
|---|---|---|
| AG NPP709syrup | Drug | AG NPP709 syrup, Ivy leaf extract syrup |
Primary outcome
improvement by global assessment
Time frame: 5 days
At closing visit, researcher assess clinical efficacy using the following five criteria (4: cure, 3: significant improvement, 2: improvement, 1: some improvement, 0: non-improvement or worsening of symptoms). Upper the Grade 3 outcomes are defined as "clinical success".
1 secondary outcome
determine safety by unwanted reaction, clinical laboratory test and physical examination
Time frame: 5 days
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 5 Oct 2010.
- Derived from this study: PubMed 41807028Cho YJ, Yoon HJ, Lim DH, Yoo KH, Choi SH, Rha YH. Randomized, Double-Blind, Multicenter, Phase 3 Study of AG NPP709 Compared With Ivy Leaf Extract in Patients With Acute or Chronic Respiratory Symptoms. J Korean Med Sci. 2026 Mar 9;41(9):e97. doi: 10.3346/jkms.2026.41.e97.
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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.
Young-ho Na, PhD, MD study director
Kyung Hee University Medical Center, Department of Pediatrics,
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AG NPP709syrup in people with Acute Upper Respiratory Tract Infections and Bronchitis, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 6 sites 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 4 inclusion and 9 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 5 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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?
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?
improvement by global assessment (time frame: 5 days). 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 NCT01151202, which also lists 1 linked publication.
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 5 Oct 2010.