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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01420445
First received: July 20, 2011
Last updated: February 23, 2012
Last verified: November 2011
History of Changes
  Purpose

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.

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.


Condition Intervention Phase
Acute Bronchitis
Chronic Bronchitis
 Drug: YHD001 dose level 1
Drug: YHD001 dose level 2
Drug: Pelargonium sidoides extract
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Change of total symptom score from baseline to the end of treatment [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety assessment [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D7.

  • time to response [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • compliance, defined by drug accountability [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: September 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YHD001 dose level 1 Drug: YHD001 dose level 1
three times daily / 7 days
Experimental: YHD001 dose level 2 Drug: YHD001 dose level 2
three times daily / 7 days
Active Comparator: Pelargonium sidoides extract Drug: Pelargonium sidoides extract
6-9mL three times daily / 7 days
Placebo Comparator: Placebo Drug: placebo
three times daily / 7 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420445

Locations
Korea, Republic of
The Catholic University of Korea Seoul St. Mary'S Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Yuhan Corporation
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01420445     History of Changes
Other Study ID Numbers: YHD001-202
Study First Received: July 20, 2011
Last Updated: February 23, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
 Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on June 18, 2013