Chronic Obstructive Pulmonary DiseasePhase 4NCT01176318
Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Erdosteine for Treatment of Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Erdosteine in people with Chronic Obstructive Pulmonary Disease, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This is a parallel group, double-blind, placebo controlled, multi-centre, randomised trial. 60 patients to be included who are adult patients admitted to hospital with a clinical diagnosis of acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Erdosteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Aug 2010to 13 Jan 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/females aged between 40-80 years
- Previous diagnosis of COPD
- Acute exacerbation of COPD requiring treatment with antibiotics and/or corticosteroids
- Symptoms of increased breathlessness, cough, sputum volume or sputum purulence
- Acute exacerbation of COPD hospitalised within 24hrs of study participation.
- On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion
Show all 9Show fewer
- Known history of cigarette smoking at least 10 pack yrs
- Willing and able to comply with study procedures
- Able to provide written informed consent to participate
Who cannot join
- Acute exacerbation of COPD within 8 weeks prior to inclusion
- Arterial blood gas on admission < pH 7.26
- Currently on treatment with mucolytics
- Patients suffering from post nasal drip, or gastro-oesophageal reflux disease
- Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus
- On long-term oxygen therapy
- Known or suspected hypersensitivity to erdosteine
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Castle Hill Hospital
Cottingham, East Yorkshire, HU16 5JQ
About this study
Official title: A Double Blind, Placebo Controlled Multicentre Study of the Effects of Standard Care Plus Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
This is a parallel group, double-blind, placebo controlled, multi-centre, randomised trial.
60 patients to be included who are adult patients admitted to hospital with a clinical diagnosis of acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Acute exacerbation of COPD will be defined as sustained worsening of the patient's condition with an increase in cough and one or more of dyspnoea, sputum volume or sputum purulence, necessitating a change in regular medication.
The primary objective of this study is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measured from baseline (Day 0) and at Day 5 of treatment, compared with standard care plus placebo.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Erdosteine, Placebo
- Keywords
- cough, exacerbation, quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErdosteineDrug
Also called erdotin
capsule 300mg twice daily for 10 days
PlaceboDrug
placebo capsule, twice daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| erdosteine | Experimental | standard care plus erdosteine for 10 days Receives: Drug: Erdosteine |
| placebo | Placebo comparator | Standard care for exacerbation of COPD plus placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hr cough recording
The primary objective is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measureing differerrence in hourly cough rate from baseline (Day 0) and Day 5 of treatment, compared with standard care plus placebo
Measured: 5 days
Secondary outcomes (1)
Quality of life questionnaire
QOL questionnaire score,Compare differece in scores recorded at baseline (day 0) and day 10, compare the difference between erdosteine plus standard care with that of standard care plus placebo.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study start10 Aug 2010 (estimated)
- Primary completion12 Oct 2011 (estimated)
- Study completion13 Jan 2012 (estimated)
Why it stopped: grant was withdrawn no financial support to conduct the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Galen Limited
- Responsible party
- Sponsor
- Investigators
- Alyn H Morice, FRCP, Principal investigator, Hull and east Yorkshire NHS trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176318
- Sponsor's protocol ID
- Erd090908
- Status last verified
- Jun 2019
- First submitted
- 4 Aug 2010
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled Multicentre Study of the Effects of Standard Care Plus Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01176318
- Acronym / sponsor ID
- Erd090908
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- cough, exacerbation, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: grant was withdrawn no financial support to conduct the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- Galen Limited
- Study start
- 10 Aug 2010 (estimated)
- Primary completion
- 12 Oct 2011 (estimated)
- Study completion
- 13 Jan 2012 (estimated)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a parallel group, double-blind, placebo controlled, multi-centre, randomised trial.
60 patients to be included who are adult patients admitted to hospital with a clinical diagnosis of acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Acute exacerbation of COPD will be defined as sustained worsening of the patient's condition with an increase in cough and one or more of dyspnoea, sputum volume or sputum purulence, necessitating a change in regular medication.
The primary objective of this study is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measured from baseline (Day 0) and at Day 5 of treatment, compared with standard care plus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erdosteine | Experimental | Drug: Erdosteinestandard care plus erdosteine for 10 days |
| placebo | Placebo comparator | Drug: PlaceboStandard care for exacerbation of COPD plus placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male/females aged between 40-80 years
- Previous diagnosis of COPD
- Acute exacerbation of COPD requiring treatment with antibiotics and/or corticosteroids
- Symptoms of increased breathlessness, cough, sputum volume or sputum purulence
- Acute exacerbation of COPD hospitalised within 24hrs of study participation.
Key exclusion criteria (7 listed)
- Acute exacerbation of COPD within 8 weeks prior to inclusion
- Arterial blood gas on admission < pH 7.26
- Currently on treatment with mucolytics
- Patients suffering from post nasal drip, or gastro-oesophageal reflux disease
- Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErdosteineAlso: erdotincapsule 300mg twice daily for 10 days | Drug | erdosteine |
| Placeboplacebo capsule, twice daily for 10 days | Drug | placebo |
Primary outcome
24 hr cough recording
Time frame: 5 days
The primary objective is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measureing differerrence in hourly cough rate from baseline (Day 0) and Day 5 of treatment, compared with standard care plus placebo
1 secondary outcome
Quality of life questionnaire
Time frame: 10 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alyn H Morice, FRCP principal investigator
Hull and east Yorkshire NHS trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erdosteine in people with Chronic Obstructive Pulmonary Disease, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hr cough recording (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.