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Mucolytic Effectiveness of Tacholiquine ® in Chronic Bronchitis

NCT02515799 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2015-08-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the mucolytic activity of Tacholiquine® compared to saline (0.9%) in chronic bronchitis patients. Lung function parameters, biomarker profiles in sputum and serum, and clinical symptoms by standardized questionnaires \[COPD activity index (CAT), Baseline Dyspnea Index (BDI) \& Transition Dyspnea Index (TDI)and the St. George's Respiratory Questionnaire (SGRQ)\] will be evaluated in response to Tacholiquine® vs. saline in chronic bronchitis patients.

Conditions

  • Bronchitis, Chronic
  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Tacholiquine

Inhaled Tacholiquine ®1% - 5ml

OTHER

Placebo

Inhaled Placebo

Sponsors & Collaborators

  • Medaimun GmbH

    collaborator OTHER

  • bene-Arzneimittel GmbH

    lead INDUSTRY

Principal Investigators

  • Stefan Zielen, Prof MD · Medaimun GmbH

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-01-31
Completion
2015-07-31

Countries

  • Germany

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515799 on ClinicalTrials.gov