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OpenTrials
Completed

NCT Number: NCT01420445

Safety/Tolerability and Efficacy of YHD001 in Patients With Acute and Chronic Bronchitis

The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo for 7 days.

The treatments will be assigned randomly to patients (n=116) with acute or chronic bronchitis.

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Key information

Conditions

Acute Bronchitis Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Bronchitis Chronic Disease Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Catholic University of Korea Seoul St. Mary'S Hospital

Seoul, 137-701, South Korea

About this study

The outcome measures is to evaluate the overall change from baseline to the end of treatment in scores relating to the severity of four symptom of bronchitis: cough, sputum, QOL of daily life, QOL of falling asleep at night.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients aged ≥18 year
  • Provision of written informed consent
  • Acute bronchitis with a Bronchitis Severity Score(BSS)≥five points

Exclusion criteria

  • History of any clinically significant disease
  • History of drug/chemical/alcohol abuse
  • Use of antibiotics, anti-histamine during the 7 days before administration of the investigational product

Treatment and study plan

YHD001 dose level 1

Drug

three times daily / 7 days

Other names: Undecided

YHD001 dose level 2

Drug

three times daily / 7 days

Other names: Undecided

Pelargonium sidoides extract

Drug

6-9mL three times daily / 7 days

Other names: UMCKAMIN Syrup

Placebo

Drug

three times daily / 7 days

Primary outcomes

  1. Change of total symptom score from baseline to the end of treatment

    Time frame: 7 days

Secondary outcomes

  1. safety assessment

    Time frame: 7 days

    comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D7.

  2. time to response

    Time frame: 7 days

  3. compliance, defined by drug accountability

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

Randomized, Double-blind, Placebo/Active-controlled, Multi-center, Phase 3 Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 After Oral Administration in Patients With Acute or Chronic Bronchitis

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 19, 2011
Registry last updated
Sep 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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