CoughPhase 3CACTUSNCT01071161
The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough
A Phase 3 study testing azithromycin in people with Cough and Chronic Obstructive Pulmonary Disease, run by Isala at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cough, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis
- What is being tested?
- azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2009to Feb 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Prior history of asthma
- Use of i.v. or oral corticosteroids and or antibiotics for an exacerbation 3 weeks before inclusion
- 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.
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- Use of macrolides the last 6 weeks prior to inclusion.
- Allergy or intolerance to macrolides.
- Other research medication started 2 months prior to inclusion.
- Prior randomisation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III (c) The Effect of Azithromycin in Patients With COPD and Chronic Productive Cough
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.
Read the detailed description
This study is a prospective double-centre, double blind randomised trial. Patients > 40 years of age, referred to our outpatient clinic with chronic cough and sputum production due to COPD will be recruited after informed consent is obtained.
Consenting patients will be randomises to a 12-week treatment with 250 mg azithromycin three times a week or placebo.
Before randomisation all patients have to fill in the SF 36 , SGRQ and the Dutch version of the Leicester Cough Questionnaire (LCQ) for assessment of the baseline quality of life and the disease specific quality of life.
The LCQ questionnaires will be performed at the beginning and every 3 weeks afterwards until 18 weeks, except the second LCQ which will be filled in after 2 weeks. Scores from this questionnaire will be used to calculate the 2-week repeatability. The SF 36 and SGRQ will be performed at the start of the study and after 12 weeks. Adverse events will be recorded during the whole treatment period. After 2 and 12 weeks a Global Rating of Change will be performed. This questionnaire will be used to validate the LCQ in COPD patients.
Randomisation will take place using a computer allocation program (BAMI-computer)
Azithromycin and placebo will be provided by Teva Pharmaceuticals. Placebo and azithromycin will be identical in appearance and packaging.
- Being tested
- azithromycin, placebo
- Keywords
- chronic cough, COPD, Azithromycin, Zithromax, LCQ
- Medical subject headings
- Cough, Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycinDrug
Also called Zithromax
azithromycin, tablets, during 12 weeks, three times a week, 250mg
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Experimental | Not described Receives: Drug: azithromycin |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the Leicester Cough Questionnaire (LCQ) scores.
Measured: 2 years
Secondary outcomes (6)
Mean change in the SF 36 and SGRQ scores.
Measured: 2 years
Change in lung function, (FEV1 (L) and FVC (L)).
Measured: 2 years
Number of exacerbations.
Measured: 2 years
Adverse reactions.
Measured: 2 years
Laboratory values: CRP, ASAT, ALAT
Measured: 2 years
Sputum analysis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startSep 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CoughStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan W.K. van den Berg, Isala
- Investigators
- Jan W van den Berg, MD, Study director, Department of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071161
- Sponsor's protocol ID
- NL19886.075.08
- Acronym
- CACTUS
- Status last verified
- Sep 2015
- First submitted
- 17 Feb 2010
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24229360Berkhof 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.
PubMed 22230731
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III (c) The Effect of Azithromycin in Patients With COPD and Chronic Productive Cough
- ClinicalTrials.gov ID
- NCT01071161
- Acronym / sponsor ID
- CACTUS / NL19886.075.08
- Keywords
- chronic cough, COPD, Azithromycin, Zithromax, LCQ
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Feb 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.
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.
Detailed description
This study is a prospective double-centre, double blind randomised trial. Patients > 40 years of age, referred to our outpatient clinic with chronic cough and sputum production due to COPD will be recruited after informed consent is obtained.
Consenting patients will be randomises to a 12-week treatment with 250 mg azithromycin three times a week or placebo.
Before randomisation all patients have to fill in the SF 36 , SGRQ and the Dutch version of the Leicester Cough Questionnaire (LCQ) for assessment of the baseline quality of life and the disease specific quality of life.
The LCQ questionnaires will be performed at the beginning and every 3 weeks afterwards until 18 weeks, except the second LCQ which will be filled in after 2 weeks. Scores from this questionnaire will be used to calculate the 2-week repeatability. The SF 36 and SGRQ will be performed at the start of the study and after 12 weeks. Adverse events will be recorded during the whole treatment period. After 2 and 12 weeks a Global Rating of Change will be performed. This questionnaire will be used to validate the LCQ in COPD patients.
Randomisation will take place using a computer allocation program (BAMI-computer)
Azithromycin and placebo will be provided by Teva Pharmaceuticals. Placebo and azithromycin will be identical in appearance and packaging.
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 |
|---|---|---|
| Azithromycin | Experimental | Drug: azithromycin |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Prior history of asthma
- Use of i.v. or oral corticosteroids and or antibiotics for an exacerbation 3 weeks before inclusion
- 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).
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 |
|---|---|---|
| azithromycinAlso: Zithromaxazithromycin, tablets, during 12 weeks, three times a week, 250mg | Drug | Azithromycin |
| placeboplacebo | Drug | Placebo |
Primary outcome
Mean change in the Leicester Cough Questionnaire (LCQ) scores.
Time frame: 2 years
6 secondary outcomes
Mean change in the SF 36 and SGRQ scores.
Time frame: 2 years
Change in lung function, (FEV1 (L) and FVC (L)).
Time frame: 2 years
Number of exacerbations.
Time frame: 2 years
Adverse reactions.
Time frame: 2 years
Laboratory values: CRP, ASAT, ALAT
Time frame: 2 years
Sputum analysis
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
- Derived from this study: PubMed 24229360Berkhof 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.
- Derived from this study: PubMed 22230731Berkhof 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.
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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.
Jan W van den Berg, MD study director
Department of Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing azithromycin in people with Cough and Chronic Obstructive Pulmonary Disease, run by Isala at 1 site in Netherlands.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 18 Sep 2015. 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in the Leicester Cough Questionnaire (LCQ) scores. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01071161, which also lists 2 linked publications.
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 18 Sep 2015.