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| Name | Class |
|---|---|
| Thai Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procaterol | Experimental | Procaterol 25 micrograms/tablet, 1 tablet twice daily for 4 weeks |
|
| Placebo | Placebo Comparator | Placebo twice daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procaterol | Drug | Procaterol 25 micrograms/tablet, 1 tablet twice daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total score from Leicester cough questionnaire | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life score from SF-36 | 2 weeks and 4 weeks | |
| Spirometric parameters (FEV1, Forced expiratory flow between 25% and 75% of vital capacity; FEF25-75%) | 2 weeks and 4 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prapaporn Pornsuriyasak, M.D. | Contact | 6622021629 | 19 | pprapaporn@gmail.com |
| Nutthanun Pongpanich | Contact | 6624019560 | 1023 | nutp@thai-otsuka.co.th |
| Name | Affiliation | Role |
|---|---|---|
| Prapaporn Pornsuriyasak, M.D. | Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University | Principal Investigator |
| Theerasuk Kawamatawong, M.D. | Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramathibodi Hospital | Recruiting | Bangkok | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7735630 | Background | 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. | |
| 180856 | Background | Blair 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 7, 2020 | |
| Reset | Feb 20, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 7, 2020 | Feb 20, 2020 |
| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D017265 | Procaterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo twice daily for 4 weeks |
|
| Impulse oscillometry parameters (airway resistance at 5 Hz, and 20 Hz, difference of airway resistance at 5 Hz and 20 Hz) |
| 2 weeks and 4 weeks |
| Provocative concentration of methacholine that induces falling of FEV1 > or= 20% (PC20) | 4 weeks |
| Study Chair |
| Poungrat Thungtitigul, M.D. | Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University | Study Director |
| 1247226 | Background | Empey 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. |
| 3059901 | Background | Nadel 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. |
| 3202451 | Background | Barnett 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. |
| 67173 | Background | Ida 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. |
| 6187791 | Background | Busse 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. |
| 1714484 | Background | Chonmaitree 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. |
| 3339502 | Background | Volovitz 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. |
| 14158494 | Background | SALEM 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. |
| 1940815 | Background | Hueston WJ. A comparison of albuterol and erythromycin for the treatment of acute bronchitis. J Fam Pract. 1991 Nov;33(5):476-80. |
| 16135178 | Background | Pornsuriyasak 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. |
| 2203180 | Background | Fuller 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. |
| 1462022 | Background | Holmes 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. |
| 8346491 | Background | Fujimura 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. |
| 8483846 | Background | Eldon MA, Battle MM, Coon MJ, Nordblom GD, Sedman AJ, Colburn WA. Clinical pharmacokinetics and relative bioavailability of oral procaterol. Pharm Res. 1993 Apr;10(4):603-5. doi: 10.1023/a:1018966506819. |
| 18825348 | Background | Raj AA, Pavord DI, Birring SS. Clinical cough IV:what is the minimal important difference for the Leicester Cough Questionnaire? Handb Exp Pharmacol. 2009;(187):311-20. doi: 10.1007/978-3-540-79842-2_16. |
| 21735384 | Background | Becker LA, Hom J, Villasis-Keever M, van der Wouden JC. Beta2-agonists for acute bronchitis. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001726. doi: 10.1002/14651858.CD001726.pub4. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D006912 | Hydroxyquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |