Cough Variant AsthmaPhase 4NCT01170429
Efficacy and Safety Study of Procaterol Hydrochloride to Treat Patients With Cough Variant Asthma (CVA)
A Phase 4 study testing Procaterol hydrochloride in people with Cough Variant Asthma, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to investigate the efficacy and safety of procaterol hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma (CVA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cough Variant Asthma
- What is being tested?
- Procaterol hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Feb 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female patients,18-75 years old;
- cough lasting over 3 weeks ; dry cough or with slight white mucous phlegm; cough is the main clinical symptom or the only symptom;
- without wheeze and fever;
- without the history of upper respiratory tract infection within recent two months; non-smoking or giving-up smoking for over two years;
- without rales from lung;
- no obvious abnormalities from chest X-ray;
- bronchial provocation test: positive.
Who cannot join
- patients with chronic pulmonary disease;
- patients who are allergic to ß2 receptor agonist;
- patients taking ß2 receptor agonist for long time;
- severe heart, renal and hepatic disease;
- unable to comply with the protocol;
- pregnant, breast feeding, and childbearing potential women;
- patients improper to the trial according to the investigators' judgment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentered, Double-blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Procaterol Hydrochloride With Inhaled Glucocorticoid in Treatment Patients With Cough Variant Asthma (CVA)
The purpose of this study is to investigate the efficacy and safety of procaterol hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma (CVA).
Read the detailed description
This is a 8-week, double-blind, randomized, placebo-controlled study, the patients with CVA will be randomized to experimental or placebo control group.
During the screening period, eligible patients will be evaluated by cough symptom score and LCQ life quality score. After 4 and 8 weeks treatment, patients will be evaluated by cough symptom score and LCQ life quality score respectively. Adverse events will also be captured at every visit.
- Conditions
- Cough Variant Asthma
- Being tested
- Procaterol hydrochloride, Meptin placebo
- Keywords
- Cough Variant Asthma, Procaterol Hydrochloride
- Medical subject headings
- Cough-Variant Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procaterol hydrochlorideDrug
Also called Meptin
25µg BID for 8 weeks
Meptin placeboDrug
Also called Meptin
25µg BID for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| I. Procaterol Hydrochloride | Experimental | Meptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks; Receives: Drug: Procaterol hydrochloride |
| II. Procaterol hydrochloride placebo | Placebo comparator | Meptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks; Receives: Drug: Meptin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient cough symptom score
Measured: 8 weeks
Therapy duration
Measured: 8 weeks
Rates of adverse events
Measured: 8 weeks
Secondary outcomes (1)
LCQ Life Quality Score
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cough Variant AsthmaStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Xin Zhou, MD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170429
- Sponsor's protocol ID
- 002-ZOC-0902i
- Status last verified
- Jun 2010
- First submitted
- 23 Jul 2010
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentered, Double-blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Procaterol Hydrochloride With Inhaled Glucocorticoid in Treatment Patients With Cough Variant Asthma (CVA)
- ClinicalTrials.gov ID
- NCT01170429
- Acronym / sponsor ID
- 002-ZOC-0902i
- Conditions
- Cough Variant Asthma
- Keywords
- Cough Variant Asthma, Procaterol Hydrochloride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 27 Jul 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 investigate the efficacy and safety of procaterol hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma (CVA).
Detailed description
This is a 8-week, double-blind, randomized, placebo-controlled study, the patients with CVA will be randomized to experimental or placebo control group.
During the screening period, eligible patients will be evaluated by cough symptom score and LCQ life quality score. After 4 and 8 weeks treatment, patients will be evaluated by cough symptom score and LCQ life quality score respectively. Adverse events will also be captured at every visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I. Procaterol Hydrochloride | Experimental | Drug: Procaterol hydrochlorideMeptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks; |
| II. Procaterol hydrochloride placebo | Placebo comparator | Drug: Meptin placeboMeptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- male or female patients,18-75 years old;
- cough lasting over 3 weeks ; dry cough or with slight white mucous phlegm; cough is the main clinical symptom or the only symptom;
- without wheeze and fever;
- without the history of upper respiratory tract infection within recent two months; non-smoking or giving-up smoking for over two years;
- without rales from lung;
Key exclusion criteria (7 listed)
- patients with chronic pulmonary disease;
- patients who are allergic to ß2 receptor agonist;
- patients taking ß2 receptor agonist for long time;
- severe heart, renal and hepatic disease;
- unable to comply with the protocol;
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 |
|---|---|---|
| Procaterol hydrochlorideAlso: Meptin25µg BID for 8 weeks | Drug | I. Procaterol Hydrochloride |
| Meptin placeboAlso: Meptin25µg BID for 8 weeks | Drug | II. Procaterol hydrochloride placebo |
Primary outcome
Patient cough symptom score
Time frame: 8 weeks
Therapy duration
Time frame: 8 weeks
Rates of adverse events
Time frame: 8 weeks
1 secondary outcome
LCQ Life Quality Score
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2010.
Related trials for Cough Variant Asthma
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.
Xin Zhou, MD principal investigator
Shanghai Jiao Tong University School of Medicine
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 Procaterol hydrochloride in people with Cough Variant Asthma, run by Shanghai Jiao Tong University School of Medicine 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 7 inclusion and 7 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 27 Jul 2010. 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 Xin Zhou (0086-21-63240090 ext. 3142, xzhou53@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient cough symptom score (time frame: 8 weeks). The study lists 3 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 27 Jul 2010.