Clinical Trial: Effect of Oral Procaterol on Postinfectious Persistent Cough

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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).

Detailed Summary:

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. W
Sponsor: Mahidol University

Current Primary Outcome: Total score from Leicester cough questionnaire [ Time Frame: up to 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Mahidol University

Dates:
Date Received: January 26, 2015
Date Started: March 2015
Date Completion: January 2018
Last Updated: March 21, 2017
Last Verified: March 2017