Effect of Oral Procaterol on Postinfectious Persistent Cough

Cough Clinical Trial

Official title:

Effect of Oral Procaterol on Chronic Persistent Cough Following Upper Respiratory Tract Infection: Double-Blind Randomized Placebo-Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02349919
• Other study ID #: 002-TOI-2014-01
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2015
• Last updated: March 21, 2017
• Start date: March 2015
• Est. completion date: January 2018

Study information

• Verified date: March 2017
• Source: Mahidol University
• Contact: Prapaporn Pornsuriyasak, M.D.
• Phone: 6622021629
• Email: pprapaporn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

1. Having persistent cough that lasts longer than 3 weeks following URTI

2. Currently being a non-smoker

3. Having normal spirometry (FEV1>or= 80% predicted)

4. Obtain consent form

Exclusion Criteria:

1. Having cough more than 8 weeks

2. Having history of allergic or intolerance to ß2 agonist

3. Having diagnosis of asthma by physicians

4. Presence of wheeze or rhonchi on physical examination

5. Having radiographic evidence of pneumonia, tuberculosis or sinusitis

6. Having significant gastroesophageal reflux symptoms suggested by GERD-Q questionnaire (GERD-Q score > 8)

7. Currently taking ACE-inhibitor

8. Being active smokers

9. Refuse to participate in the study

Related Conditions & MeSH terms

• Cough
• Respiratory Tract Infections

Intervention

Drug:
• Procaterol
Procaterol 25 micrograms/tablet, 1 tablet twice daily for 4 weeks
• Placebo
Placebo twice daily for 4 weeks

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Thai Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Thailand, 

References & Publications (18)

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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. — View Citation

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. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total score from Leicester cough questionnaire		up to 4 weeks
Secondary	Quality of life score from SF-36		2 weeks and 4 weeks
Secondary	Spirometric parameters (FEV1, Forced expiratory flow between 25% and 75% of vital capacity; FEF25-75%)		2 weeks and 4 weeks
Secondary	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
Secondary	Provocative concentration of methacholine that induces falling of FEV1 > or= 20% (PC20)		4 weeks