Effect of Oral Procaterol on Postinfectious Persistent Cough

Not Applicable

• Conditions: Cough
• Interventions: Drug: Placebo; Drug: Procaterol

• Registration Number: NCT02349919
• Lead Sponsor: Mahidol University

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 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 Timeline

• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-01-28
• Study First Posted: 2015-01-29
• Study Start: 2015-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-23
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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 β2 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo twice daily for 4 weeks
Procaterol	Procaterol	Procaterol 25 micrograms/tablet, 1 tablet twice daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Total score from Leicester cough questionnaire	up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
Spirometric parameters (FEV1, Forced expiratory flow between 25% and 75% of vital capacity; FEF25-75%)	2 weeks and 4 weeks
Provocative concentration of methacholine that induces falling of FEV1 > or= 20% (PC20)	4 weeks
Quality of life score from SF-36	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

Trial Locations

Locations (1)

Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand