evalutation of the antitussive effect of Erdosteine in patients with chronic bronchitis

Effects of short term Erdosteine treatment on chronic cough on bronchitis phenotypes of COPD - Erdostein and cough

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000620-14-IT

Enrollment

Registered

2011-12-16

Start date

2011-12-22

Completion date

Unknown

Last updated

2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD MedDRA version: 14.1 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: ERDOTIN*30CPS 300MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: erdostein Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 300- Pharmaceutica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with clinical diagnosis of COPD and chronic bronchitis complaining from chronic cough Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: - female of child-bearing potential; - pregnant or breast-feeding women; - lack of efficient contraception; - clinically significant or unstable concurrent disease, such as recent myocardial infarction, unstable coronary artery disease, heart failure NYHA class III IV; - signifcant epatic and renal impairment; - gastrointestinal disease (eg. active peptic ulcere); - other significant comorbidities; - change of the ongoing therapeutic COPD regimen in the last two weeks prior to the study; - known or suspected ipersensitivity to Erdosteine; - partecipation in another clinical study in the preceding sixty days

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluation of the anti-tussive activity of Erdostein;Secondary Objective: Effect of Erdosteine on response to a cough challenge with citric acid;Primary end point(s): - VAS score of cough sensitivity; - Cough score from the Leicester Cough Questionnaire; - cough sensitivity;Timepoint(s) of evaluation of this end point: 15 days	—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: n.a.	—

Countries

Italy

Contacts

Public ContactPneumologia e Fisiopatologia Resp.

Azienda Ospedaliero-Universitaria Careggi

giovanni.fontana@unifi.it055 7947516

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026