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CompletedNCT02515799Tacho-COPDUpdated Aug 5, 2015

Mucolytic Effectiveness of Tacholiquine ® in Chronic Bronchitis

A Phase 4 interventional study of Tacholiquine and Placebo in Bronchitis, Chronic and Pulmonary Disease, Chronic Obstructive, sponsored by bene-Arzneimittel GmbH. Completed at 1 site in Germany. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-08-05.

Sponsored by bene-Arzneimittel GmbH · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

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.

Read the 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.

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Conditions studied

  • Bronchitis, Chronic
  • Pulmonary Disease, Chronic Obstructive
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In context

Bronchitis

268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.

This study's enrollment of 27 is below the median of 120 across 184 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

This is the only study on the registry with bene-Arzneimittel GmbH as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
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Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
27 participants (actual)

Study arms

  • Active comparator
    Tacholiquine

    Inhalation

    Drug: Tacholiquine

  • Placebo comparator
    Saline Solution 0,9%

    Inhalation

    Other: Placebo

Interventions

  • DrugTacholiquine

    Inhaled Tacholiquine ®1% - 5ml

  • OtherPlacebo

    Inhaled Placebo

    Also known as: isotonic saline solution (0.9%)

06

What researchers measure

Primary outcomes

  1. Change of sputum weight before, during and after treatment

    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

    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)

Secondary outcomes

  1. COPD Assessment Test (CAT)

    Symptom Score

    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)

  2. Baseline Dyspnoea Index (BDI)

    Symptom Score

    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)

  3. transition dyspnoea index (TDI)

    Symptom Score

    Time frame: Visit 1 (day 0), Visit 3 (day 21±3), Visit 4 (day 28±3), Visit 6 (day 21±3 after Visit 4)

  4. ease of sputum production

    Ease is measured by analog scale

    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)

  5. Change in Forced vital capacity (FVC)

    lung function parameter

    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)

  6. change in forced expiratory volume at one second (FEV1)

    lung function parameter

    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)

  7. Forced Expiratory Flow at 75% (FEF25)

    lung function parameter

    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)

  8. Residual Volume (RV)

    lung function parameter

    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)

  9. Ratio of Residual Volume to Total Lung Capacity( RV/TLC)

    lung function parameter

    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)

  10. 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)

  11. CrP

    Plasma biomarker profile

    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)

  12. Lipopolysaccharide-binding protein (LBP)

    Plasma biomarker profile

    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)

  13. Interleukin 6 (IL-6)

    Plasma biomarker profile

    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)

07

Study locations

1 site
  • Medaimun GmbH
    Frankfurt/M, Hessen 60596, Germany
08

References and documents

Publications

  • Decramer M, Janssens W. Mucoactive therapy in COPD. Eur Respir Rev. 2010 Jun;19(116):134-40. doi: 10.1183/09059180.00003610. PubMed 20956182 ↗
  • Paez PN, Miller WF. Surface active agents in sputum evacuation: a blind comparison with normal saline solution and distilled water. Chest. 1971 Oct;60(4):312-7. doi: 10.1378/chest.60.4.312. No abstract available. PubMed 4940230 ↗
  • Eickmeier O, Huebner M, Herrmann E, Zissler U, Rosewich M, Baer PC, Buhl R, Schmitt-Grohe S, Zielen S, Schubert R. Sputum biomarker profiles in cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) and association between pulmonary function. Cytokine. 2010 May;50(2):152-7. doi: 10.1016/j.cyto.2010.02.004. Epub 2010 Feb 23. PubMed 20181491 ↗
  • Koppitz M, Eschenburg C, Salzmann E, Rosewich M, Schubert R, Zielen S. Mucolytic Effectiveness of Tyloxapol in Chronic Obstructive Pulmonary Disease - A Double-Blind, Randomized Controlled Trial. PLoS One. 2016 Jun 16;11(6):e0156999. doi: 10.1371/journal.pone.0156999. eCollection 2016. PubMed 27308826 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02515799
Lead sponsor
bene-Arzneimittel GmbH
Collaborators
Medaimun GmbH
Responsible party
Sponsor
First posted
Aug 5, 2015
Start date
Aug 2014
Primary completion
Jan 2015
Completion
Jul 2015
Last update
Aug 5, 2015

Study contacts

Stefan Zielen, Prof MD
principal investigator · Medaimun GmbH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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