NCT02349919

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

January 26, 2015

Last Update Submit

March 21, 2017

Conditions

Cough

Keywords

postinfectious cough, postviral cough

Outcome Measures

Primary Outcomes (1)

  • Total score from Leicester cough questionnaire

    up to 4 weeks

Secondary Outcomes (4)

  • 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

  • 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 Arms (2)

Procaterol

EXPERIMENTAL

Procaterol 25 micrograms/tablet, 1 tablet twice daily for 4 weeks

Drug: Procaterol

Placebo

PLACEBO COMPARATOR

Placebo twice daily for 4 weeks

Drug: Placebo

Interventions

ProcaterolDRUG

Procaterol 25 micrograms/tablet, 1 tablet twice daily for 4 weeks

Also known as: procaterol hydrochloride
Procaterol
PlaceboDRUG

Placebo twice daily for 4 weeks

Placebo

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • Currently taking ACE-inhibitor
  • Being active smokers
  • Refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramathibodi Hospital

Bangkok, Bangkok, 10400, Thailand

RECRUITING

Related Publications (18)

  • 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.

    PMID: 7735630BACKGROUND

  • 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.

    PMID: 180856BACKGROUND

  • 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.

    PMID: 1247226BACKGROUND

  • 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.

    PMID: 3059901BACKGROUND

  • 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.

    PMID: 3202451BACKGROUND

  • 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.

    PMID: 67173BACKGROUND

  • 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.

    PMID: 6187791BACKGROUND

  • 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.

    PMID: 1714484BACKGROUND

  • 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.

    PMID: 3339502BACKGROUND

  • 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.

    PMID: 14158494BACKGROUND

  • Hueston WJ. A comparison of albuterol and erythromycin for the treatment of acute bronchitis. J Fam Pract. 1991 Nov;33(5):476-80.

    PMID: 1940815BACKGROUND

  • 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.

    PMID: 16135178BACKGROUND

  • 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.

    PMID: 2203180BACKGROUND

  • 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.

    PMID: 1462022BACKGROUND

  • 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.

    PMID: 8346491BACKGROUND

  • 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.

    PMID: 8483846BACKGROUND

  • 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.

    PMID: 18825348BACKGROUND

  • 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.

    PMID: 21735384BACKGROUND

MeSH Terms

Conditions

Cough

Interventions

Procaterol

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesHydroxyquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • 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

    STUDY CHAIR

  • Poungrat Thungtitigul, M.D.

    Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University

    STUDY DIRECTOR

Central Study Contacts

Prapaporn Pornsuriyasak, M.D.

CONTACT

6622021629pprapaporn@gmail.com

Nutthanun Pongpanich

CONTACT

6624019560nutp@thai-otsuka.co.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2015

First Posted

January 29, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

March 23, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Locations

TH(1)