Clinical trial NCT02349919: Effect of Oral Procaterol on Postinfectious Persistent Cough
Official title: Effect of Oral Procaterol on Chronic Persistent Cough Following Upper Respiratory Tract Infection: Double-Blind Randomized Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cough
Keywords: postinfectious cough, postviral cough
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Thai Otsuka Pharmaceutical Co., Ltd.
First posted: 2015-01-29
Enrollment: 74
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total score from Leicester cough questionnaire
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Quality of life score from SF-36
timeFrame: 2 weeks and 4 weeks
measure: Spirometric parameters (FEV1, Forced expiratory flow between 25% and 75% of vital capacity; FEF25-75%)
timeFrame: 2 weeks and 4 weeks
measure: Impulse oscillometry parameters (airway resistance at 5 Hz, and 20 Hz, difference of airway resistance at 5 Hz and 20 Hz)
timeFrame: 2 weeks and 4 weeks
measure: Provocative concentration of methacholine that induces falling of FEV1 > or= 20% (PC20)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
Study officials:
affiliation: Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University
name: Prapaporn Pornsuriyasak, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University
name: Theerasuk Kawamatawong, M.D.
role: STUDY_CHAIR
affiliation: Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University
name: Poungrat Thungtitigul, M.D.
role: STUDY_DIRECTOR
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