drugset / Trial / NCT02515799
Mucolytic Effectiveness of Tacholiquine ® in Chronic Bronchitis
RandomizedCrossoverQuadruple-blindSupportive care
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.
Timeline
- Start
- 2014-08
- Primary completion
- 2015-01
- Completion
- 2015-07
Publications
- Background Decramer M, Janssens W. Mucoactive therapy in COPD. Eur Respir Rev. 2010 Jun;19(116):134-40. doi: 10.1183/09059180.00003610.
- Results 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.
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | TYLOXAPOL | Unknown | 1 % | Inhaled |
| Comparator | TYLOXAPOL | Unknown | 5 ml | Inhaled |