CoughNCT02349919
Effect of Oral Procaterol on Postinfectious Persistent Cough
A study testing Procaterol in people with Cough, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to investigate the effectiveness of oral procaterol in treatment of non-asthmatic patients who suffer from persistent cough following upper respiratory tract infection (URTI). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cough
- What is being tested?
- Procaterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2015to Jan 2018
- Phase
- Interventional
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Having persistent cough that lasts longer than 3 weeks following URTI
- Currently being a non-smoker
- Having normal spirometry (FEV1>or= 80% predicted)
- Obtain consent form
Who cannot join
- Having cough more than 8 weeks
- Having history of allergic or intolerance to β2 agonist
- Having diagnosis of asthma by physicians
- Presence of wheeze or rhonchi on physical examination
- Having radiographic evidence of pneumonia, tuberculosis or sinusitis
- Having significant gastroesophageal reflux symptoms suggested by GERD-Q questionnaire (GERD-Q score > 8)
Show all 9Show fewer
- Currently taking ACE-inhibitor
- Being active smokers
- Refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Ramathibodi Hospital
Bangkok, Bangkok, 10400
Prapaporn Pornsuriyasak, M.D., 662011629 ext. 19, pprapaporn@gmail.com
Theerasuk Kawamatawong, M.D., 662011629, ktheerasuk@hotmail.com
About this study
Official title: Effect of Oral Procaterol on Chronic Persistent Cough Following Upper Respiratory Tract Infection: Double-Blind Randomized Placebo-Controlled Trial
The purpose of this study is to investigate the effectiveness of oral procaterol in treatment of non-asthmatic patients who suffer from persistent cough following upper respiratory tract infection (URTI).
Read the detailed description
Persistent cough following upper respiratory tract infection (URTI) is a common problem in the clinical practice, namely post-infectious cough. The potential mechanisms are viral-induced airway epithelial damage that leads to 1) airway hyperresponsiveness and airway narrowing, 2) increase in vascular permeability resulting in airway edema, and 3) activation of inflammatory mediators from inflammatory cells resulting in airway smooth muscle contraction. It is usually spontaneously resolved, although various therapeutic trials have been used with unpredictable results. Regarding to bronchodilators, inhaled ipratropium was effective in reducing cough symptom in a small study (N=14). We conduct a double-blind randomized placebo-controlled trial to investigate the effectiveness of oral procaterol, as a bronchodilator, in non-asthmatic adult patients suffering from persistent cough post URTI.
Eligible patients who have cough lasting longer than 3 weeks post URTI with normal spirometry will be randomized to receive either placebo or procaterol (25 microgram twice daily) for 4 weeks.
The primary outcome is cough symptom score using Leicester cough questionnaire (LCQ). The secondary outcomes are pulmonary function tests (spirometry, impulse oscillometry) and exhaled nitric oxide and quality of life (SF-36). All outcomes are measured at baseline, 2 weeks, and 4 weeks. Bronchoprovocation test with methacholine is performed at baseline and 4 weeks to determine the provocative concentration of methacholine that induces falling of FEV1 >or =20%. Adverse events will be recorded every visit.
Data analysis will be in both intention-to-treat and per-protocol fashion. A linear mixed-effect regression model will be applied to assess treatment effect on LCQ score, SF-36, and lung function. Within-subject variation will be fitted in the model as random effects whereas the treatment will be considered as a fixed effect. Time at measurement (i.e., 2- and 4-week) will also be included in the mixed model by treating it as fixed-effect. Marginal treatment effects between treatments and time will be then estimated and compared.
- Conditions
- Cough
- Being tested
- Procaterol, Placebo
- Keywords
- postinfectious cough, postviral cough
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProcaterolDrug
Also called procaterol hydrochloride
Procaterol 25 micrograms/tablet, 1 tablet twice daily for 4 weeks
PlaceboDrug
Placebo twice daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Procaterol | Experimental | Procaterol 25 micrograms/tablet, 1 tablet twice daily for 4 weeks Receives: Drug: Procaterol |
| Placebo | Placebo comparator | Placebo twice daily for 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score from Leicester cough questionnaire
Measured: up to 4 weeks
Secondary outcomes (4)
Quality of life score from SF-36
Measured: 2 weeks and 4 weeks
Spirometric parameters (FEV1, Forced expiratory flow between 25% and 75% of vital capacity; FEF25-75%)
Measured: 2 weeks and 4 weeks
Impulse oscillometry parameters (airway resistance at 5 Hz, and 20 Hz, difference of airway resistance at 5 Hz and 20 Hz)
Measured: 2 weeks and 4 weeks
Provocative concentration of methacholine that induces falling of FEV1 > or= 20% (PC20)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Mahidol 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Thai Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Prapaporn Pornsuriyasak, M.D., Principal investigator, Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol UniversityTheerasuk Kawamatawong, M.D., Study chair, Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol UniversityPoungrat Thungtitigul, M.D., Study director, Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349919
- Sponsor's protocol ID
- 002-TOI-2014-01
- Status last verified
- Mar 2017
- First submitted
- 26 Jan 2015
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hegele RG, Hayashi S, Hogg JC, Pare PD. Mechanisms of airway narrowing and hyperresponsiveness in viral respiratory tract infections. Am J Respir Crit Care Med. 1995 May;151(5):1659-64; discussion 1664-5. doi: 10.1164/ajrccm.151.5.7735630.
PubMed 7735630Blair HT, Greenberg SB, Stevens PM, Bilunos PA, Couch RB. Effects of rhinovirus infection of pulmonary function of healthy human volunteers. Am Rev Respir Dis. 1976 Jul;114(1):95-102. doi: 10.1164/arrd.1976.114.1.95.
PubMed 180856Empey DW, Laitinen LA, Jacobs L, Gold WM, Nadel JA. Mechanisms of bronchial hyperreactivity in normal subjects after upper respiratory tract infection. Am Rev Respir Dis. 1976 Feb;113(2):131-9. doi: 10.1164/arrd.1976.113.2.131.
PubMed 1247226Nadel JA. Some epithelial metabolic factors affecting airway smooth muscle. Am Rev Respir Dis. 1988 Dec;138(6 Pt 2):S22-3. doi: 10.1164/ajrccm/138.6_Pt_2.S22.
PubMed 3059901Barnett K, Jacoby DB, Nadel JA, Lazarus SC. The effects of epithelial cell supernatant on contractions of isolated canine tracheal smooth muscle. Am Rev Respir Dis. 1988 Oct;138(4):780-3. doi: 10.1164/ajrccm/138.4.780.
PubMed 3202451Ida S, Hooks JJ, Siraganian RP, Notkins AL. Enhancement of IgE-mediated histamine release from human basophils by viruses: role of interferon. J Exp Med. 1977 Apr 1;145(4):892-906. doi: 10.1084/jem.145.4.892.
PubMed 67173Busse WW, Swenson CA, Borden EC, Treuhaft MW, Dick EC. Effect of influenza A virus on leukocyte histamine release. J Allergy Clin Immunol. 1983 Apr;71(4):382-8. doi: 10.1016/0091-6749(83)90066-0.
PubMed 6187791Chonmaitree T, Lett-Brown MA, Grant JA. Respiratory viruses induce production of histamine-releasing factor by mononuclear leukocytes: a possible role in the mechanism of virus-induced asthma. J Infect Dis. 1991 Sep;164(3):592-4. doi: 10.1093/infdis/164.3.592.
PubMed 1714484Volovitz B, Faden H, Ogra PL. Release of leukotriene C4 in respiratory tract during acute viral infection. J Pediatr. 1988 Feb;112(2):218-22. doi: 10.1016/s0022-3476(88)80058-1.
PubMed 3339502SALEM H, AVIADO DM. ANTITUSSIVE DRUGS, WITH SPECIAL REFERENCE TO A NEW THEORY FOR THE INITATION OF THE COUGH REFLEX AND THE INFLUENCE OR BRONCHODILATORS. Am J Med Sci. 1964 May;247:585-600. No abstract available.
PubMed 14158494Hueston WJ. A comparison of albuterol and erythromycin for the treatment of acute bronchitis. J Fam Pract. 1991 Nov;33(5):476-80.
PubMed 1940815Pornsuriyasak P, Charoenpan P, Vongvivat K, Thakkinstian A. Inhaled corticosteroid for persistent cough following upper respiratory tract infection. Respirology. 2005 Sep;10(4):520-4. doi: 10.1111/j.1440-1843.2005.00732.x.
PubMed 16135178Fuller RW, Jackson DM. Physiology and treatment of cough. Thorax. 1990 Jun;45(6):425-30. doi: 10.1136/thx.45.6.425. No abstract available.
PubMed 2203180Holmes PW, Barter CE, Pierce RJ. Chronic persistent cough: use of ipratropium bromide in undiagnosed cases following upper respiratory tract infection. Respir Med. 1992 Sep;86(5):425-9. doi: 10.1016/s0954-6111(06)80010-7.
PubMed 1462022Fujimura M, Sakamoto S, Kamio Y, Bando T, Kurashima K, Matsuda T. Effect of inhaled procaterol on cough receptor sensitivity to capsaicin in patients with asthma or chronic bronchitis and in normal subjects. Thorax. 1993 Jun;48(6):615-8. doi: 10.1136/thx.48.6.615.
PubMed 8346491
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Procaterol on Chronic Persistent Cough Following Upper Respiratory Tract Infection: Double-Blind Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02349919
- Acronym / sponsor ID
- 002-TOI-2014-01
- Conditions
- Cough
- Keywords
- postinfectious cough, postviral cough
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Thai Otsuka Pharmaceutical Co., Ltd.
- Study start
- Mar 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 29 Jan 2015 (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 effectiveness of oral procaterol in treatment of non-asthmatic patients who suffer from persistent cough following upper respiratory tract infection (URTI).
Detailed description
Persistent cough following upper respiratory tract infection (URTI) is a common problem in the clinical practice, namely post-infectious cough. The potential mechanisms are viral-induced airway epithelial damage that leads to 1) airway hyperresponsiveness and airway narrowing, 2) increase in vascular permeability resulting in airway edema, and 3) activation of inflammatory mediators from inflammatory cells resulting in airway smooth muscle contraction. It is usually spontaneously resolved, although various therapeutic trials have been used with unpredictable results. Regarding to bronchodilators, inhaled ipratropium was effective in reducing cough symptom in a small study (N=14). We conduct a double-blind randomized placebo-controlled trial to investigate the effectiveness of oral procaterol, as a bronchodilator, in non-asthmatic adult patients suffering from persistent cough post URTI.
Eligible patients who have cough lasting longer than 3 weeks post URTI with normal spirometry will be randomized to receive either placebo or procaterol (25 microgram twice daily) for 4 weeks.
The primary outcome is cough symptom score using Leicester cough questionnaire (LCQ). The secondary outcomes are pulmonary function tests (spirometry, impulse oscillometry) and exhaled nitric oxide and quality of life (SF-36). All outcomes are measured at baseline, 2 weeks, and 4 weeks. Bronchoprovocation test with methacholine is performed at baseline and 4 weeks to determine the provocative concentration of methacholine that induces falling of FEV1 >or =20%. Adverse events will be recorded every visit.
Data analysis will be in both intention-to-treat and per-protocol fashion. A linear mixed-effect regression model will be applied to assess treatment effect on LCQ score, SF-36, and lung function. Within-subject variation will be fitted in the model as random effects whereas the treatment will be considered as a fixed effect. Time at measurement (i.e., 2- and 4-week) will also be included in the mixed model by treating it as fixed-effect. Marginal treatment effects between treatments and time will be then estimated and compared.
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 |
|---|---|---|
| Procaterol | Experimental | Drug: ProcaterolProcaterol 25 micrograms/tablet, 1 tablet twice daily for 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo twice daily for 4 weeks |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Having persistent cough that lasts longer than 3 weeks following URTI
- Currently being a non-smoker
- Having normal spirometry (FEV1>or= 80% predicted)
- Obtain consent form
Key exclusion criteria (9 listed)
- Having cough more than 8 weeks
- Having history of allergic or intolerance to β2 agonist
- Having diagnosis of asthma by physicians
- Presence of wheeze or rhonchi on physical examination
- Having radiographic evidence of pneumonia, tuberculosis or sinusitis
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 |
|---|---|---|
| ProcaterolAlso: procaterol hydrochlorideProcaterol 25 micrograms/tablet, 1 tablet twice daily for 4 weeks | Drug | Procaterol |
| PlaceboPlacebo twice daily for 4 weeks | Drug | Placebo |
Primary outcome
Total score from Leicester cough questionnaire
Time frame: up to 4 weeks
4 secondary outcomes
Quality of life score from SF-36
Time frame: 2 weeks and 4 weeks
Spirometric parameters (FEV1, Forced expiratory flow between 25% and 75% of vital capacity; FEF25-75%)
Time frame: 2 weeks and 4 weeks
Impulse oscillometry parameters (airway resistance at 5 Hz, and 20 Hz, difference of airway resistance at 5 Hz and 20 Hz)
Time frame: 2 weeks and 4 weeks
Provocative concentration of methacholine that induces falling of FEV1 > or= 20% (PC20)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Background: PubMed 7735630Hegele RG, Hayashi S, Hogg JC, Pare PD. Mechanisms of airway narrowing and hyperresponsiveness in viral respiratory tract infections. Am J Respir Crit Care Med. 1995 May;151(5):1659-64; discussion 1664-5. doi: 10.1164/ajrccm.151.5.7735630.
- Background: PubMed 180856Blair HT, Greenberg SB, Stevens PM, Bilunos PA, Couch RB. Effects of rhinovirus infection of pulmonary function of healthy human volunteers. Am Rev Respir Dis. 1976 Jul;114(1):95-102. doi: 10.1164/arrd.1976.114.1.95.
- Background: PubMed 1247226Empey DW, Laitinen LA, Jacobs L, Gold WM, Nadel JA. Mechanisms of bronchial hyperreactivity in normal subjects after upper respiratory tract infection. Am Rev Respir Dis. 1976 Feb;113(2):131-9. doi: 10.1164/arrd.1976.113.2.131.
- Background: PubMed 3059901Nadel JA. Some epithelial metabolic factors affecting airway smooth muscle. Am Rev Respir Dis. 1988 Dec;138(6 Pt 2):S22-3. doi: 10.1164/ajrccm/138.6_Pt_2.S22.
- Background: PubMed 3202451Barnett K, Jacoby DB, Nadel JA, Lazarus SC. The effects of epithelial cell supernatant on contractions of isolated canine tracheal smooth muscle. Am Rev Respir Dis. 1988 Oct;138(4):780-3. doi: 10.1164/ajrccm/138.4.780.
- Background: PubMed 67173Ida S, Hooks JJ, Siraganian RP, Notkins AL. Enhancement of IgE-mediated histamine release from human basophils by viruses: role of interferon. J Exp Med. 1977 Apr 1;145(4):892-906. doi: 10.1084/jem.145.4.892.
- Background: PubMed 6187791Busse WW, Swenson CA, Borden EC, Treuhaft MW, Dick EC. Effect of influenza A virus on leukocyte histamine release. J Allergy Clin Immunol. 1983 Apr;71(4):382-8. doi: 10.1016/0091-6749(83)90066-0.
- Background: PubMed 1714484Chonmaitree T, Lett-Brown MA, Grant JA. Respiratory viruses induce production of histamine-releasing factor by mononuclear leukocytes: a possible role in the mechanism of virus-induced asthma. J Infect Dis. 1991 Sep;164(3):592-4. doi: 10.1093/infdis/164.3.592.
- Background: PubMed 3339502Volovitz B, Faden H, Ogra PL. Release of leukotriene C4 in respiratory tract during acute viral infection. J Pediatr. 1988 Feb;112(2):218-22. doi: 10.1016/s0022-3476(88)80058-1.
- Background: PubMed 14158494SALEM H, AVIADO DM. ANTITUSSIVE DRUGS, WITH SPECIAL REFERENCE TO A NEW THEORY FOR THE INITATION OF THE COUGH REFLEX AND THE INFLUENCE OR BRONCHODILATORS. Am J Med Sci. 1964 May;247:585-600. No abstract available.
- Background: PubMed 1940815Hueston WJ. A comparison of albuterol and erythromycin for the treatment of acute bronchitis. J Fam Pract. 1991 Nov;33(5):476-80.
- Background: PubMed 16135178Pornsuriyasak P, Charoenpan P, Vongvivat K, Thakkinstian A. Inhaled corticosteroid for persistent cough following upper respiratory tract infection. Respirology. 2005 Sep;10(4):520-4. doi: 10.1111/j.1440-1843.2005.00732.x.
- Individual participant dataSharing planned: Yes
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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.
Prapaporn Pornsuriyasak, M.D. principal investigator
Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University
Theerasuk Kawamatawong, M.D. study chair
Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University
Poungrat Thungtitigul, M.D. study director
Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procaterol in people with Cough, run by Mahidol University at 1 site in Thailand.
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: status not confirmed, as of the sponsor's last update on 23 Mar 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 Thailand. 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.
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 Prapaporn Pornsuriyasak, M.D. (6622021629 ext. 19, pprapaporn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score from Leicester cough questionnaire (time frame: up to 4 weeks). 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 NCT02349919, which also lists 18 linked publications.
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 23 Mar 2017.