Mucolytic Effectiveness of Tacholiquine ® in Chronic Bronchitis

NCT02515799 | Completed Phase 4

• 1 other identifier: 268/14
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive

Outcome Measures

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

  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 (13)

• COPD Assessment Test (CAT)

  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)

• Baseline Dyspnoea Index (BDI)

  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)

• transition dyspnoea index (TDI)

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

• ease of sputum production

  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)

• Change in Forced vital capacity (FVC)

  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)

Study Arms (2)

Tacholiquine

ACTIVE COMPARATOR

Inhalation

Drug: Tacholiquine

Saline Solution 0,9%

PLACEBO COMPARATOR

Inhalation

Other: Placebo

Interventions

Tacholiquine DRUG

Inhaled Tacholiquine ®1% - 5ml

Tacholiquine

Placebo OTHER

Inhaled Placebo

Also known as: isotonic saline solution (0.9%)

Saline Solution 0,9%

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures.
• Female or male subjects aged 40-85 years inclusive at Visit 1.
• 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).
• Current smoker or ex-smoker with a tobacco history of ≥10 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year).
• 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
• At least a CAT value \> 10 at Visit 1.
• Presence of chronic cough and sputum production either "several days per week" or "almost every day"

You may not qualify if:

• 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).
• 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
• 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.
• Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 4 weeks prior to (Visit 1).
• Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 4 weeks prior to (Visit 1).
• History of anaphylaxis to Tacholiquine®.
• 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.
• 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.
• Use of immunosuppressive medication, including rectal corticosteroids, high potency topical corticosteroids and systemic steroids within 28 days prior to (Visit 1).

Sponsors & Collaborators

• bene-Arzneimittel GmbH: lead
• Medaimun GmbH: collaborator

Study Sites (1)

Medaimun GmbH

Frankfurt/M, Hesse, 60596, Germany

Location

Related Publications (4)

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

  PMID: 20956182 BACKGROUND

• 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.

  PMID: 4940230 RESULT

• 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.

  PMID: 20181491 RESULT

• 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.

  PMID: 27308826 DERIVED

MeSH Terms

Conditions

Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive

Interventions

tacholiquine

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Zielen, Prof MD

  Medaimun GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: August 5, 2015
• Study Start: August 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

DE (1)