NCT02515799: Tacho-COPD

A Double-blind, Placebo Controlled, Randomized Crossover Trial to Characterize the Mucolytic Effectiveness of Tacholiquine® in Chronic Bronchitis

Completed Phase 4 Last updated 2 August 2015

What this trial tests

Phase 4 trial testing Tacholiquine in Bronchitis, Chronic in 27 participants. Completed in 1 July 2015.

Timeline

1 August 2014

Primary endpoint
1 January 2015

1 July 2015

Quick facts

Lead sponsor	bene-Arzneimittel GmbH
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	supportive care
Enrollment	27
Start date	1 August 2014
Primary completion	1 January 2015
Estimated completion	1 July 2015
Sites	1 location across Germany

Drugs / interventions tested

• Tacholiquine — full drug profile →
• Placebo

Conditions studied

• Bronchitis, Chronic — all drugs for Bronchitis, Chronic →
• Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

bene-Arzneimittel GmbH — full company profile →

Who can join

Adults 40 to 85, any sex, with Bronchitis, Chronic or Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mucolytic Effectiveness of Tyloxapol in Chronic Obstructive Pulmonary Disease - A Double-Blind, Randomized Controlled Trial.
   Koppitz M, Eschenburg C, Salzmann E, Rosewich M, et al · · 2016 · cited 5× · PMID 27308826 · DOI 10.1371/journal.pone.0156999
2. The COPD Pipeline XXX.
   Gross N. · · 2015 · cited 1× · PMID 28848873 · DOI 10.15326/jcopdf.3.1.2015.0181