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Mucolytic Effectiveness of Tacholiquine ® in Chronic Bronchitis (Tacho-COPD)

This study has been completed.
Sponsor:
Collaborator:
Medaimun GmbH
Information provided by (Responsible Party):
bene-Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT02515799
First received: July 24, 2015
Last updated: August 2, 2015
Last verified: August 2015
  Purpose
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.

Condition Intervention Phase
Bronchitis, Chronic
Pulmonary Disease, Chronic Obstructive
Drug: Tacholiquine
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Double-blind, Placebo Controlled, Randomized Crossover Trial to Characterize the Mucolytic Effectiveness of Tacholiquine® in Chronic Bronchitis

Resource links provided by NLM:


Further study details as provided by bene-Arzneimittel GmbH:

Primary Outcome Measures:
  • Change of sputum weight before, during and after treatment [ Time Frame: Visit 1 (day 0), Visit 2 (day 7 ±1), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 5 (day 7±1 after Visit 4), Visit 6 (day 21±3 after Visit 4) ]
    Active Treatment for 3 weeks compared with Placebo (Saline solution 0.9%), 3 inhalations with 5 ml solution via nebulizer per day of study treatment during 21 consecutive days


Secondary Outcome Measures:
  • COPD Assessment Test (CAT) [ Time Frame: Visit 1 (day 0), Visit 2 (day 7 ±1), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 5 (day 7±1 after Visit 4), Visit 6 (day 21±3 after Visit 4) ]
    Symptom Score

  • Baseline Dyspnoea Index (BDI) [ Time Frame: Visit 1 (day 0), Visit 2 (day 7 ±1), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 5 (day 7±1 after Visit 4), Visit 6 (day 21±3 after Visit 4) ]
    Symptom Score

  • transition dyspnoea index (TDI) [ Time Frame: Visit 1 (day 0), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 6 (day 21±3 after Visit 4) ]
    Symptom Score

  • ease of sputum production [ Time Frame: Visit 1 (day 0), Visit 2 (day 7 ±1), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 5 (day 7±1 after Visit 4), Visit 6 (day 21±3 after Visit 4) ]
    Ease is measured by analog scale

  • Change in Forced vital capacity (FVC) [ Time Frame: Visit 1 (day 0), Visit 2 (day 7 ±1), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 5 (day 7±1 after Visit 4), Visit 6 (day 21±3 after Visit 4) ]
    lung function parameter

  • change in forced expiratory volume at one second (FEV1) [ Time Frame: Visit 1 (day 0), Visit 2 (day 7 ±1), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 5 (day 7±1 after Visit 4), Visit 6 (day 21±3 after Visit 4) ]
    lung function parameter

  • Forced Expiratory Flow at 75% (FEF25) [ Time Frame: Visit 1 (day 0), Visit 2 (day 7 ±1), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 5 (day 7±1 after Visit 4), Visit 6 (day 21±3 after Visit 4) ]
    lung function parameter

  • Residual Volume (RV) [ Time Frame: Visit 1 (day 0), Visit 2 (day 7 ±1), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 5 (day 7±1 after Visit 4), Visit 6 (day 21±3 after Visit 4) ]
    lung function parameter

  • Ratio of Residual Volume to Total Lung Capacity( RV/TLC) [ Time Frame: Visit 1 (day 0), Visit 2 (day 7 ±1), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 5 (day 7±1 after Visit 4), Visit 6 (day 21±3 after Visit 4) ]
    lung function parameter

  • Sputum biomarker profiles (IL-1, IL-6, IL-8) [ Time Frame: Visit 1 (day 0), Visit 2 (day 7 ±1), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 5 (day 7±1 after Visit 4), Visit 6 (day 21±3 after Visit 4) ]
  • CrP [ Time Frame: Visit 1 (day 0), Visit 2 (day 7 ±1), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 5 (day 7±1 after Visit 4), Visit 6 (day 21±3 after Visit 4) ]
    Plasma biomarker profile

  • Lipopolysaccharide-binding protein (LBP) [ Time Frame: Visit 1 (day 0), Visit 2 (day 7 ±1), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 5 (day 7±1 after Visit 4), Visit 6 (day 21±3 after Visit 4) ]
    Plasma biomarker profile

  • Interleukin 6 (IL-6) [ Time Frame: Visit 1 (day 0), Visit 2 (day 7 ±1), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 5 (day 7±1 after Visit 4), Visit 6 (day 21±3 after Visit 4) ]
    Plasma biomarker profile


Enrollment: 27
Study Start Date: August 2014
Study Completion Date: July 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tacholiquine
Inhalation
Drug: Tacholiquine
Inhaled Tacholiquine ®1% - 5ml
Placebo Comparator: Saline Solution 0,9%
Inhalation
Other: Placebo
Inhaled Placebo
Other Name: isotonic saline solution (0.9%)

Detailed Description:

The aim of the study is to compare Tacholiquine ® and saline (0.9%) regarding their ability to promote the discharge of mucus from the respiratory passages in patients with chronic bronchitis (COPD). Alleviated discharge of mucus should ease breathing, improve subjective wellbeing, reduce inflammation in the air passages and improve lung function.

Determine the magnitude of the effect of Tacholiquine ® compared to saline (0.9%) in chronic bronchitis patients. Lung function parameters, biomarker profiles in sputum and serum, and clinical symptoms and quality of life by standardized questionnaires [COPD activity index (CAT), Baseline Dyspnea Index (BDI) & Transition Dyspnea Index (TDI), St George's respiratory Quality of Life Questionnaire] will be evaluated in response to Tacholiquine ® vs. saline at day one and at end of treatment.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures.
  2. Female or male subjects aged 40-85 years inclusive at Visit 1.
  3. Documented history of COPD with a post-bronchodilator FEV1/FVC<0.70 and a post-bronchodilator FEV1<80% of predicted normal value at screening (spirometry will be used for this criteria assessment).
  4. Current smoker or ex-smoker with a tobacco history of ≥10 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year).
  5. Women of childbearing potential (WOCBP) must use a highly effective form of birth control (confirmed by the Investigator).

    − Women >50 years old would be considered postmenopausal

  6. At least a CAT value > 10 at Visit 1.
  7. Presence of chronic cough and sputum production either "several days per week" or "almost every day"

Exclusion Criteria:

  1. Clinically important pulmonary disease other than COPD (e.g. active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency and primary ciliary dyskinesia) or another diagnosed pulmonary or systemic disease that is associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
  2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:

    • Affect the safety of the subject throughout the study
    • Influence the findings of the study or their interpretation
    • Impede the subject's ability to complete the entire duration of study
  3. Documented Unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, renal failure, uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator that in Investigator's judgment may put the patient at risk or negatively affect the outcome of the study.
  4. Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 4 weeks prior to (Visit 1).
  5. Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 4 weeks prior to (Visit 1).
  6. Pneumonia within 4 weeks prior to (Visit 1), based on the last day of antibiotic treatment or hospitalization date, whatever occurred later. The subject cannot be re-screened if this exclusion criterion is met.
  7. History of anaphylaxis to Tacholiquine®.
  8. Long term oxygen therapy (LTOT) defined as need for oxygen > 4L 02 flow with signs and/or symptoms of cor pulmonale, right ventricular failure or evidence by echocardiogram or pulmonary artery catheterization of moderate to severe pulmonary hypertension. In order to be admitted to the trial subjects on LTOT have to be ambulatory and be able to attend clinic visits.
  9. Any clinically significant abnormal findings in physical examination, vital signs, hematology, or urinalysis during Visit 1, which, in the opinion of the Investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to complete entire duration of the study.
  10. Use of immunosuppressive medication, including rectal corticosteroids, high potency topical corticosteroids and systemic steroids within 28 days prior to (Visit 1).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02515799

Locations
Germany
Medaimun GmbH
Frankfurt/M, Hessen, Germany, 60596
Sponsors and Collaborators
bene-Arzneimittel GmbH
Medaimun GmbH
Investigators
Principal Investigator: Stefan Zielen, Prof MD Medaimun GmbH
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: bene-Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT02515799     History of Changes
Other Study ID Numbers: 268/14
Study First Received: July 24, 2015
Last Updated: August 2, 2015

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

ClinicalTrials.gov processed this record on May 25, 2017