NCT01071161

Brief Summary

The purpose of this study is to demonstrate the efficacy of azithromycin to produce a significant change in the cough-related health status, measured with the Dutch version of the Leicester Cough Questionnaire in patiënts with COPD gold classification 2-4 and chronic productive coughing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

2.4 years

First QC Date

February 17, 2010

Last Update Submit

September 17, 2015

Conditions

CoughChronic Obstructive Pulmonary DiseaseChronic Bronchitis

Keywords

chronic coughCOPDAzithromycinZithromaxLCQ

Outcome Measures

Primary Outcomes (1)

  • Mean change in the Leicester Cough Questionnaire (LCQ) scores.

    2 years

Secondary Outcomes (6)

  • Mean change in the SF 36 and SGRQ scores.

    2 years

  • Change in lung function, (FEV1 (L) and FVC (L)).

    2 years

  • Number of exacerbations.

    2 years

  • Adverse reactions.

    2 years

  • Laboratory values: CRP, ASAT, ALAT

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Azithromycin

EXPERIMENTAL
Drug: azithromycin

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

azithromycinDRUG

azithromycin, tablets, during 12 weeks, three times a week, 250mg

Also known as: Zithromax
Azithromycin
placeboDRUG

placebo

Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> 40 years of age, in our outpatient clinic with chronic cough and COPD (gold2-4)
  • Chronic cough is defined as a cough \> 12 weeks duration, at least 12 weeks a year in 2 subsequent years.
  • Analysed for bronchiectasis prior to participation by CT-thorax.

You may not qualify if:

  • Prior history of asthma
  • Patients suffering from other relevant lung diseases.
  • Clinically relevant abnormal laboratory values suggesting an unknown disease requiring further clinical evaluation.
  • Liver disease, (ALAT and/or ASAT levels two or more times the upper limit of normal).
  • Pregnancy or lactation.
  • Allergy or intolerance to macrolides.
  • Prior randomisation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala Klinieken

Zwolle, Overijssel, 8011 JW, Netherlands

Location

Related Publications (2)

  • Berkhof FF, Doornewaard-ten Hertog NE, Uil SM, Kerstjens HA, van den Berg JW. Azithromycin and cough-specific health status in patients with chronic obstructive pulmonary disease and chronic cough: a randomised controlled trial. Respir Res. 2013 Nov 14;14(1):125. doi: 10.1186/1465-9921-14-125.

    PMID: 24229360DERIVED

  • Berkhof FF, Boom LN, ten Hertog NE, Uil SM, Kerstjens HA, van den Berg JW. The validity and precision of the Leicester Cough Questionnaire in COPD patients with chronic cough. Health Qual Life Outcomes. 2012 Jan 9;10:4. doi: 10.1186/1477-7525-10-4.

    PMID: 22230731DERIVED

MeSH Terms

Conditions

CoughPulmonary Disease, Chronic ObstructiveBronchitis, ChronicChronic Cough

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Jan W van den Berg, MD

    Department of Pulmonology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 19, 2010

Study Start

September 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

September 18, 2015

Record last verified: 2015-09

Locations

NL(1)