Mucolytic Effectiveness of Tacholiquine ® in Chronic Bronchitis

NCT ID: NCT02515799

Last Updated: 2015-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-07-31

Brief 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.

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.

Conditions

Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Tacholiquine

Inhalation

Group Type: ACTIVE_COMPARATOR

Tacholiquine

Intervention Type: DRUG

Inhaled Tacholiquine ®1% - 5ml

Saline Solution 0,9%

Inhalation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Inhaled Placebo

Interventions

Tacholiquine

Inhaled Tacholiquine ®1% - 5ml

Intervention Type: DRUG

Placebo

Inhaled Placebo

Intervention Type: OTHER

Other Intervention Names

isotonic saline solution (0.9%)

Eligibility 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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medaimun GmbH

OTHER

Sponsor Role: collaborator

bene-Arzneimittel GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Zielen, Prof MD

Role: PRINCIPAL_INVESTIGATOR

Medaimun GmbH

Locations

Medaimun GmbH

Frankfurt/M, Hesse, Germany

Countries

Germany

References

Decramer M, Janssens W. Mucoactive therapy in COPD. Eur Respir Rev. 2010 Jun;19(116):134-40. doi: 10.1183/09059180.00003610.

Reference Type: BACKGROUND

PMID: 20956182 (View on PubMed)

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.

Reference Type: RESULT

PMID: 4940230 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20181491 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27308826 (View on PubMed)

Other Identifiers

268/14

Identifier Type: -

Identifier Source: org_study_id