AsthmaPhase 4NCT01584804
Effects of Su-Huang Antitussive Capsule on Cough Variant Asthma
A Phase 4 study testing Su-Huang antitussive capsule and Sugar pill in people with Asthma, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study aims to observe the therapeutic effect of Su-Huang antitussive capsule on cough variant asthma. The investigators hypothesize: Cough score and cough reflex sensitivity will be improved after treatment with Su-Huang antitussive capsule. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Su-Huang antitussive capsule and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Aug 2013
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have a history of cough as sole or main symptom lasting more than 8 weeks, often irritating cough more cough at night.
- Patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge.
- There is evidence that bronchodilator treatment* is efficient for cough symptom (symptom score improved 1 at least).
- Patients whose chest x-ray outcome was normal or without any active focus.
- Patients who was aged from 18 years old (≥ 18 years old ) to 65 years old (≤ 75 years old).
Who cannot join
- Patients demonstrate FEV1/FVC <70% in lung function test. FEV1 stands for forced expiratory volume in 1 second, FVC stands for forced vital capacity.
- Patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history >10 pack-years or equivalence.
- Patients with concomitance of GERC (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, ACEI induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction.
- Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
- Subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
- Subjects who have received any therapy in the previous seven days, e.g. long-acting β2 agonist, theophylline sustained release.
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- Subjects who have received oral/ inhaled/systematic corticosteroid in the previous 4 weeks.
- Subjects who are diagnosed with past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. e.g.nasal-sinus infection, lower respiratory tract infection, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia.
- Subjects who demonstrate significant abnormality on biochemistry, hematology, ECG.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, 520120
Kefang Lai, PHD, klai@163.com
Kefang Lai, PHD
About this study
Official title: Randomised, Double-blinded, Placebo-Controlled Study of Therapeutic Effect of Su-Huang Antitussive Capsule on Cough Variant Asthma(CVA)
This study aims to observe the therapeutic effect of Su-Huang antitussive capsule on cough variant asthma.
The investigators hypothesize:
Cough score and cough reflex sensitivity will be improved after treatment with Su-Huang antitussive capsule.
Read the detailed description
Study groups:
60 patients diagnosed with CVA will be randomised into two groups as follows:
Group 1:Su-Huang antitussive capsule The patients with cough variant asthma received Su-Huang antitussive capsule (0.45g) 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal).
Group 2: placebo The patients with cough variant asthma received placebo 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal).
The study will be divided into following phases:
- First Visit (Visit s, day -14): A full medical history and physical examination to be undertaken to determine whether patients meet the inclusion/exclusion criteria. After the informed consent has been signed, the following samples are obtained from all patients: blood samples for routine clinical laboratory tests (haematology, biochemistry and electrocardiogram, chest x-ray). A urine pregnancy test will be performed in women of childbearing potential. Spirometry and methacholine bronchial provocation test were performed to determined the presence of bronchial non-specific hyper-responsiveness.
- Screening Period (day -14 to day 0, 14 Days) Patients can take medications other than corticosteroid , β2 agonist, inhaled sodium cromoglycate.
- Second Visit (Visit 1, Week 0): Patients are given the Diary Card. A physical examination were to be performed. All laboratory tests results are obtained to determine whether patients meet the inclusion/exclusion criteria. Concurrent medication were recorded. Capsaicin challenge test and FENO were performed and hypertonic saline induced sputum samples for cell differential were taken from enrolled patients. Enrolled patients were randomized into different groups, and the study medication were dispensed.
- During Treatment 1(Week 0 to Week 1, 7 days): Patients were to take study medication for 14 days and completed Diary Card for 7 days from Week 0 to Week 1.
- Third Visit (Visit 2, Week 1): A physical examination were to be performed. The Diary Card were collected and reviewed. Adverse events, secondary complications, concurrent medication will be recorded. The Diary Card were collected, reviewed and assessed whether treatment is efficient for cough symptom (symptom score improved 1 at least).
- During Treatment 2 (Week 1 to Week 2, 7 days):
Patients were to take study medication for 14 days and completed Diary Card for 7 days from Week 1 to Week 2.
Spirometry and bronchial provocation test by methacholine inhalation,electro-cardiogram,capsaicin challenge test and FENO were performed and hypertonic saline induced sputum samples for cell differential were taken from enrolled patients.
Blood samples for routine clinical laboratory tests (haematology and biochemistry) were obtained, if a clinically significant laboratory abnormal result was noted at the visit 2, AE and a follow-up visit would be considered.
- Conditions
- Asthma
- Being tested
- Su-Huang antitussive capsule, Sugar pill
- Keywords
- Su Huang antitussive capsule, Cough variant asthma, Placebo
- Medical subject headings
- Asthma, Cough-Variant Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Su-Huang antitussive capsuleDrug
Su-Huang antitussive capsule (0.45g) 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal)
Sugar pillDrug
Sugar pill 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal)
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Active comparator | Monotherapy with Su-Huang antitussive capsule Receives: Drug: Su-Huang antitussive capsule |
| Sugar pill | Placebo comparator | Monotherapy with placebo Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day-time and night-time cough symptom total-score changes from baseline to visit 3
Measured: 2 weeks
Secondary outcomes (1)
Cough reflex sensitivity changes in 2 groups at baseline and visit 3. Cell differential changes in hypertonic saline induced sputum in 2 groups at baseline and visit3.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Mengfeng Li, MD, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584804
- Sponsor's protocol ID
- 2003L03253
- Status last verified
- Nov 2012
- First submitted
- 24 Apr 2012
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blinded, Placebo-Controlled Study of Therapeutic Effect of Su-Huang Antitussive Capsule on Cough Variant Asthma(CVA)
- ClinicalTrials.gov ID
- NCT01584804
- Acronym / sponsor ID
- 2003L03253
- Conditions
- Asthma
- Keywords
- Su Huang antitussive capsule, Cough variant asthma, Placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 25 Apr 2012 (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.
This study aims to observe the therapeutic effect of Su-Huang antitussive capsule on cough variant asthma.
The investigators hypothesize:
Cough score and cough reflex sensitivity will be improved after treatment with Su-Huang antitussive capsule.
Detailed description
Study groups:
60 patients diagnosed with CVA will be randomised into two groups as follows:
Group 1:Su-Huang antitussive capsule The patients with cough variant asthma received Su-Huang antitussive capsule (0.45g) 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal).
Group 2: placebo The patients with cough variant asthma received placebo 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal).
The study will be divided into following phases:
- First Visit (Visit s, day -14): A full medical history and physical examination to be undertaken to determine whether patients meet the inclusion/exclusion criteria. After the informed consent has been signed, the following samples are obtained from all patients: blood samples for routine clinical laboratory tests (haematology, biochemistry and electrocardiogram, chest x-ray). A urine pregnancy test will be performed in women of childbearing potential. Spirometry and methacholine bronchial provocation test were performed to determined the presence of bronchial non-specific hyper-responsiveness.
- Screening Period (day -14 to day 0, 14 Days) Patients can take medications other than corticosteroid , β2 agonist, inhaled sodium cromoglycate.
- Second Visit (Visit 1, Week 0): Patients are given the Diary Card. A physical examination were to be performed. All laboratory tests results are obtained to determine whether patients meet the inclusion/exclusion criteria. Concurrent medication were recorded. Capsaicin challenge test and FENO were performed and hypertonic saline induced sputum samples for cell differential were taken from enrolled patients. Enrolled patients were randomized into different groups, and the study medication were dispensed.
- During Treatment 1(Week 0 to Week 1, 7 days): Patients were to take study medication for 14 days and completed Diary Card for 7 days from Week 0 to Week 1.
- Third Visit (Visit 2, Week 1): A physical examination were to be performed. The Diary Card were collected and reviewed. Adverse events, secondary complications, concurrent medication will be recorded. The Diary Card were collected, reviewed and assessed whether treatment is efficient for cough symptom (symptom score improved 1 at least).
- During Treatment 2 (Week 1 to Week 2, 7 days):
Patients were to take study medication for 14 days and completed Diary Card for 7 days from Week 1 to Week 2.
Spirometry and bronchial provocation test by methacholine inhalation,electro-cardiogram,capsaicin challenge test and FENO were performed and hypertonic saline induced sputum samples for cell differential were taken from enrolled patients.
Blood samples for routine clinical laboratory tests (haematology and biochemistry) were obtained, if a clinically significant laboratory abnormal result was noted at the visit 2, AE and a follow-up visit would be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Active comparator | Drug: Su-Huang antitussive capsuleMonotherapy with Su-Huang antitussive capsule |
| Sugar pill | Placebo comparator | Drug: Sugar pillMonotherapy with placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have a history of cough as sole or main symptom lasting more than 8 weeks, often irritating cough more cough at night.
- Patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge.
- There is evidence that bronchodilator treatment* is efficient for cough symptom (symptom score improved 1 at least).
- Patients whose chest x-ray outcome was normal or without any active focus.
- Patients who was aged from 18 years old (≥ 18 years old ) to 65 years old (≤ 75 years old).
Key exclusion criteria (9 listed)
- Patients demonstrate FEV1/FVC <70% in lung function test. FEV1 stands for forced expiratory volume in 1 second, FVC stands for forced vital capacity.
- Patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history >10 pack-years or equivalence.
- Patients with concomitance of GERC (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, ACEI induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction.
- Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
- Subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
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 |
|---|---|---|
| Su-Huang antitussive capsuleSu-Huang antitussive capsule (0.45g) 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal) | Drug | Monotherapy |
| Sugar pillSugar pill 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal) | Drug | Sugar pill |
Primary outcome
Day-time and night-time cough symptom total-score changes from baseline to visit 3
Time frame: 2 weeks
1 secondary outcome
Cough reflex sensitivity changes in 2 groups at baseline and visit 3. Cell differential changes in hypertonic saline induced sputum in 2 groups at baseline and visit3.
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
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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.
Mengfeng Li, MD study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Su-Huang antitussive capsule and Sugar pill in people with Asthma, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 19 Nov 2012. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Kefang Lai, PhD (8620 83062893, klai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day-time and night-time cough symptom total-score changes from baseline to visit 3 (time frame: 2 weeks). 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 19 Nov 2012.