Effect of Oral Procaterol on Postinfectious Persistent Cough

March 21, 2017 updated by: Mahidol University

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Ramathibodi hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Procaterol
Procaterol 25 micrograms/tablet, 1 tablet twice daily for 4 weeks
Drug: Procaterol
Procaterol 25 micrograms/tablet, 1 tablet twice daily for 4 weeks
Other Names:
  • procaterol hydrochloride
Placebo Comparator: Placebo
Placebo twice daily for 4 weeks
Drug: Placebo
Placebo twice daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total score from Leicester cough questionnaire
Time Frame: up to 4 weeks
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life score from SF-36
Time Frame: 2 weeks and 4 weeks
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
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
2 weeks and 4 weeks
Provocative concentration of methacholine that induces falling of FEV1 > or= 20% (PC20)
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Thai Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Prapaporn Pornsuriyasak, M.D., Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University
  • Study Chair: Theerasuk Kawamatawong, M.D., Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University
  • Study Director: Poungrat Thungtitigul, M.D., Pulmonary and Critical Care, Department of Medicine, Ramathibodi Hospital, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002-TOI-2014-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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