Pulmonary Disease, Chronic ObstructiveRECUTNCT02386735
Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD
A study testing Prednisone in people with Pulmonary Disease, Chronic Obstructive and Adverse Effect of Glucocorticoids and Synthetic Analogues, run by Prof. Dr. Jörg Leuppi at 1 site in Switzerland.
Trial summary
Background Chronic obstructive pulmonary disease (COPD) is a major public health issue with no curative treatment. In Switzerland estimated 5-7% of the total population are suffering from this chronic disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Adverse Effect of Glucocorticoids and Synthetic Analogues, Disease Exacerbation
- What is being tested?
- Prednisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to 31 Jul 2024
- Phase
- Interventional
- 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
- Informed Consent as documented by signature
- Age ≥40 years
- History of ≥10 pack-years of smoking (past or present smokers)
- Airway obstruction, defined as FEV1/FVC≤70%
- Current acute exacerbation of COPD by clinical criteria, defined by the presence of at least two of the following:
- Change of baseline dyspnea
- Change of cough
- Change of sputum quantity or purulence
Who cannot join
- Diagnosis of asthma
- Initial necessity of hospitalization
- Women who are pregnant or breast feeding
- Premenopausal women with insufficient contraception and anamnestic risk for pregnancy
- Severe coexisting disease with life expectancy <6 months
- Diagnosis of tuberculosis
Show all 10Show fewer
- Known severe immunosuppression or immunosuppression after solid organ or stem cell transplantation
- Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Participation in another study involving an investigational drug
- Previous enrolment into the current study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD - a Randomized, Double-blind, Non-inferiority Study (The "RECUT"-Trial)
Background
Chronic obstructive pulmonary disease (COPD) is a major public health issue with no curative treatment. In Switzerland estimated 5-7% of the total population are suffering from this chronic disease. According to current guidelines corticosteroids are part of treatment of acute exacerbations in COPD patients. Several studies suggest that corticosteroids accelerate the recovery of forced expiratory volume in 1 second (FEV1), decrease duration of hospitalization, reduce treatment failure rate and improve clinical outcome. The additional therapeutic benefit on FEV1-recovery tough seems only to last for three to five days. The investigators recently published a hospital-based study showing that in patients presenting to emergency departments with acute exacerbation of COPD, a short five day treatment with systemic steroids was not inferior to a conventional 14 day treatment with regard to re-exacerbation. Cumulative corticosteroid dose could be reduced in this trial. To the investigators knowledge no data is available about the minimal necessary corticosteroid dose in an outpatient treatment setting so far.
Read more
Aim
The primary aim of this study is to investigate in an outpatient setting, whether a three day treatment with orally administered systemic corticosteroids is non-inferior to a five day treatment in acute exacerbation of COPD and if total glucocorticoid exposure can be reduced by shorter therapy.
Hypothesis
The investigators postulate, that in an outpatient setting, where generally less severe exacerbations are being treated, a three day treatment duration of systemic corticosteroids should be non-inferior to a five day treatment duration with regard to treatment benefits but decrease cumulative corticosteroid exposure.
Design and Setting
This study is going to be performed as a prospective, randomized, double-blind, placebo-controlled, non-inferiority trial in an outpatient setting. Randomization will be performed as block randomization with a 1:1 allocation. The investigators are going to recruit GPs in northwestern and central Switzerland.
Methods
The investigators are going to include patients presenting to GP's with acute exacerbation of COPD. When matching the investigators eligibility criteria and written informed consent is given, patients included in the study are receiving systemic corticosteroid treatment (equivalent of 40mg prednisone daily) for either five days (conventional arm) or three days (interventional arm) followed by two days of placebo for the interventional group. Pre-randomized, identically looking, numbered blisters are given to all patients included in the study. Antibiotic treatment (Amoxicillin/Clavulanic acid, 625mg 3/d, for ten days) is given to all patients with a CRP ≥50mg/l, COPD and known diagnosis of bronchiectasis, as well as patients presenting with all three of the following symptoms: change of baseline dyspnea, change of sputum quantity and sputum purulence. Further initial treatment and steroid treatment after inclusion is determined and documented by the GP. Patients will undergo follow-up visits at day three and seven by their GP as well as follow-up phone calls executed by the study center at day 30, 90 and 180.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Adverse Effect of Glucocorticoids and Synthetic Analogues, Disease Exacerbation
- Being tested
- Placebo, Prednisone
- Keywords
- Corticosteroid treatment, COPD, Primary Health Care, Randomized controlled trial
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Three days prednisone 40mg, two days placebo
PrednisoneDrug
Five days prednisone 40mg.
| Study group | Role | What they receive |
|---|---|---|
| Investigational treatment | Experimental | Patients included in the placebo group are receiving systemic corticosteroid treatment (equivalent of 40mg prednisone daily) for three days followed by two days of placebo. Receives: Drug: Placebo |
| Standard treatment | Active comparator | Patients included in the control group are receiving systemic corticosteroid treatment (equivalent of 40mg prednisone daily) for five days as recommended in current guidelines. Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to next exacerbation
Measured: Six month follow-up period after index exacerbation.
Secondary outcomes (5)
Cumulative glucocorticoid dose
Measured: Six month follow-up period after index exacerbation.
Glucocorticoid side effects and complications
Measured: Six month follow-up period after index exacerbation.
Change in FEV1
Measured: 7 days follow-up period after index exacerbation.
Hospitalization rate during index exacerbation
Measured: Six month follow-up period after index exacerbation.
Overall mortality
Measured: Six month follow-up period after index exacerbation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: Low recruitment rate, motivation and engagement of participating GPs unfortunately declined over time, as well as the financial resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Jörg Leuppi
- Sponsor type
- University, hospital or other
- Collaborators
- Institut für Hausarztmedizin Basel, Kantonsspital Baselland Bruderholz
- Responsible party
- Sponsor-investigator, Prof. Dr. Jörg Leuppi, Cantonal Hospital, Baselland
- Investigators
- Joerg D. Leuppi, Prof., Principal investigator, Kantonsspital Basleland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386735
- Sponsor's protocol ID
- KSBL2015-017
- Acronym
- RECUT
- Status last verified
- Mar 2025
- First submitted
- 11 Feb 2015
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Leuppi JD, Miedinger D, Chhajed PN, Buess C, Schafroth S, Bucher HC, Tamm M. Quality of spirometry in primary care for case finding of airway obstruction in smokers. Respiration. 2010;79(6):469-74. doi: 10.1159/000243162. Epub 2009 Sep 26.
PubMed 19786731Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002 Oct;57(10):847-52. doi: 10.1136/thorax.57.10.847.
PubMed 12324669Makris D, Moschandreas J, Damianaki A, Ntaoukakis E, Siafakas NM, Milic Emili J, Tzanakis N. Exacerbations and lung function decline in COPD: new insights in current and ex-smokers. Respir Med. 2007 Jun;101(6):1305-12. doi: 10.1016/j.rmed.2006.10.012. Epub 2006 Nov 16.
PubMed 17112715Barnes PJ. Chronic obstructive pulmonary disease. N Engl J Med. 2000 Jul 27;343(4):269-80. doi: 10.1056/NEJM200007273430407. No abstract available.
PubMed 10911010Sapey E, Stockley RA. COPD exacerbations . 2: aetiology. Thorax. 2006 Mar;61(3):250-8. doi: 10.1136/thx.2005.041822.
PubMed 16517585Sethi S, Murphy TF. Infection in the pathogenesis and course of chronic obstructive pulmonary disease. N Engl J Med. 2008 Nov 27;359(22):2355-65. doi: 10.1056/NEJMra0800353. No abstract available.
PubMed 19038881Mohan A, Chandra S, Agarwal D, Guleria R, Broor S, Gaur B, Pandey RM. Prevalence of viral infection detected by PCR and RT-PCR in patients with acute exacerbation of COPD: a systematic review. Respirology. 2010 Apr;15(3):536-42. doi: 10.1111/j.1440-1843.2010.01722.x.
PubMed 20415983Leuppi JD, Schuetz P, Bingisser R, Bodmer M, Briel M, Drescher T, Duerring U, Henzen C, Leibbrandt Y, Maier S, Miedinger D, Muller B, Scherr A, Schindler C, Stoeckli R, Viatte S, von Garnier C, Tamm M, Rutishauser J. Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial. JAMA. 2013 Jun 5;309(21):2223-31. doi: 10.1001/jama.2013.5023.
PubMed 23695200Albert RK, Martin TR, Lewis SW. Controlled clinical trial of methylprednisolone in patients with chronic bronchitis and acute respiratory insufficiency. Ann Intern Med. 1980 Jun;92(6):753-8. doi: 10.7326/0003-4819-92-6-753.
PubMed 6770731Emerman CL, Connors AF, Lukens TW, May ME, Effron D. A randomized controlled trial of methylprednisolone in the emergency treatment of acute exacerbations of COPD. Chest. 1989 Mar;95(3):563-7. doi: 10.1378/chest.95.3.563.
PubMed 2920584Bullard MJ, Liaw SJ, Tsai YH, Min HP. Early corticosteroid use in acute exacerbations of chronic airflow obstruction. Am J Emerg Med. 1996 Mar;14(2):139-43. doi: 10.1016/S0735-6757(96)90120-5.
PubMed 8924134Thompson WH, Nielson CP, Carvalho P, Charan NB, Crowley JJ. Controlled trial of oral prednisone in outpatients with acute COPD exacerbation. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):407-12. doi: 10.1164/ajrccm.154.2.8756814.
PubMed 8756814Aaron SD, Vandemheen KL, Hebert P, Dales R, Stiell IG, Ahuja J, Dickinson G, Brison R, Rowe BH, Dreyer J, Yetisir E, Cass D, Wells G. Outpatient oral prednisone after emergency treatment of chronic obstructive pulmonary disease. N Engl J Med. 2003 Jun 26;348(26):2618-25. doi: 10.1056/NEJMoa023161.
PubMed 12826636Niewoehner DE, Erbland ML, Deupree RH, Collins D, Gross NJ, Light RW, Anderson P, Morgan NA. Effect of systemic glucocorticoids on exacerbations of chronic obstructive pulmonary disease. Department of Veterans Affairs Cooperative Study Group. N Engl J Med. 1999 Jun 24;340(25):1941-7. doi: 10.1056/NEJM199906243402502.
PubMed 10379017Davies L, Angus RM, Calverley PM. Oral corticosteroids in patients admitted to hospital with exacerbations of chronic obstructive pulmonary disease: a prospective randomised controlled trial. Lancet. 1999 Aug 7;354(9177):456-60. doi: 10.1016/s0140-6736(98)11326-0.
PubMed 10465169
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD - a Randomized, Double-blind, Non-inferiority Study (The "RECUT"-Trial)
- ClinicalTrials.gov ID
- NCT02386735
- Acronym / sponsor ID
- RECUT / KSBL2015-017
- Conditions
- Pulmonary Disease, Chronic Obstructive, Adverse Effect of Glucocorticoids and Synthetic Analogues, Disease Exacerbation
- Keywords
- Corticosteroid treatment, COPD, Primary Health Care, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate, motivation and engagement of participating GPs unfortunately declined over time, as well as the financial resources.
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Prof. Dr. Jörg LeuppiUniversity, hospital or other
- Collaborators
- Institut für Hausarztmedizin Basel, Kantonsspital Baselland Bruderholz
- Study start
- Mar 2015
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 12 Mar 2015 (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.
Background
Chronic obstructive pulmonary disease (COPD) is a major public health issue with no curative treatment. In Switzerland estimated 5-7% of the total population are suffering from this chronic disease. According to current guidelines corticosteroids are part of treatment of acute exacerbations in COPD patients. Several studies suggest that corticosteroids accelerate the recovery of forced expiratory volume in 1 second (FEV1), decrease duration of hospitalization, reduce treatment failure rate and improve clinical outcome. The additional therapeutic benefit on FEV1-recovery tough seems only to last for three to five days. The investigators recently published a hospital-based study showing that in patients presenting to emergency departments with acute exacerbation of COPD, a short five day treatment with systemic steroids was not inferior to a conventional 14 day treatment with regard to re-exacerbation. Cumulative corticosteroid dose could be reduced in this trial. To the investigators knowledge no data is available about the minimal necessary corticosteroid dose in an outpatient treatment setting so far.
Aim
The primary aim of this study is to investigate in an outpatient setting, whether a three day treatment with orally administered systemic corticosteroids is non-inferior to a five day treatment in acute exacerbation of COPD and if total glucocorticoid exposure can be reduced by shorter therapy.
Hypothesis
The investigators postulate, that in an outpatient setting, where generally less severe exacerbations are being treated, a three day treatment duration of systemic corticosteroids should be non-inferior to a five day treatment duration with regard to treatment benefits but decrease cumulative corticosteroid exposure.
Design and Setting
This study is going to be performed as a prospective, randomized, double-blind, placebo-controlled, non-inferiority trial in an outpatient setting. Randomization will be performed as block randomization with a 1:1 allocation. The investigators are going to recruit GPs in northwestern and central Switzerland.
Methods
The investigators are going to include patients presenting to GP's with acute exacerbation of COPD. When matching the investigators eligibility criteria and written informed consent is given, patients included in the study are receiving systemic corticosteroid treatment (equivalent of 40mg prednisone daily) for either five days (conventional arm) or three days (interventional arm) followed by two days of placebo for the interventional group. Pre-randomized, identically looking, numbered blisters are given to all patients included in the study. Antibiotic treatment (Amoxicillin/Clavulanic acid, 625mg 3/d, for ten days) is given to all patients with a CRP ≥50mg/l, COPD and known diagnosis of bronchiectasis, as well as patients presenting with all three of the following symptoms: change of baseline dyspnea, change of sputum quantity and sputum purulence. Further initial treatment and steroid treatment after inclusion is determined and documented by the GP. Patients will undergo follow-up visits at day three and seven by their GP as well as follow-up phone calls executed by the study center at day 30, 90 and 180.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational treatment | Experimental | Drug: PlaceboPatients included in the placebo group are receiving systemic corticosteroid treatment (equivalent of 40mg prednisone daily) for three days followed by two days of placebo. |
| Standard treatment | Active comparator | Drug: PrednisonePatients included in the control group are receiving systemic corticosteroid treatment (equivalent of 40mg prednisone daily) for five days as recommended in current guidelines. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed Consent as documented by signature
- Age ≥40 years
- History of ≥10 pack-years of smoking (past or present smokers)
- Airway obstruction, defined as FEV1/FVC≤70%
- Current acute exacerbation of COPD by clinical criteria, defined by the presence of at least two of the following:
Key exclusion criteria (10 listed)
- Diagnosis of asthma
- Initial necessity of hospitalization
- Women who are pregnant or breast feeding
- Premenopausal women with insufficient contraception and anamnestic risk for pregnancy
- Severe coexisting disease with life expectancy <6 months
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 |
|---|---|---|
| PlaceboThree days prednisone 40mg, two days placebo | Drug | Investigational treatment |
| PrednisoneFive days prednisone 40mg. | Drug | Standard treatment |
Primary outcome
Time to next exacerbation
Time frame: Six month follow-up period after index exacerbation.
5 secondary outcomes
Cumulative glucocorticoid dose
Time frame: Six month follow-up period after index exacerbation.
Glucocorticoid side effects and complications
Time frame: Six month follow-up period after index exacerbation.
Change in FEV1
Time frame: 7 days follow-up period after index exacerbation.
Hospitalization rate during index exacerbation
Time frame: Six month follow-up period after index exacerbation.
Overall mortality
Time frame: Six month follow-up period after index exacerbation.
Results and safety
The study was stopped early (reason given: Low recruitment rate, motivation and engagement of participating GPs unfortunately declined over time, as well as the financial resources.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 19786731Leuppi JD, Miedinger D, Chhajed PN, Buess C, Schafroth S, Bucher HC, Tamm M. Quality of spirometry in primary care for case finding of airway obstruction in smokers. Respiration. 2010;79(6):469-74. doi: 10.1159/000243162. Epub 2009 Sep 26.
- Background: PubMed 12324669Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002 Oct;57(10):847-52. doi: 10.1136/thorax.57.10.847.
- Background: PubMed 17112715Makris D, Moschandreas J, Damianaki A, Ntaoukakis E, Siafakas NM, Milic Emili J, Tzanakis N. Exacerbations and lung function decline in COPD: new insights in current and ex-smokers. Respir Med. 2007 Jun;101(6):1305-12. doi: 10.1016/j.rmed.2006.10.012. Epub 2006 Nov 16.
- Background: PubMed 10911010Barnes PJ. Chronic obstructive pulmonary disease. N Engl J Med. 2000 Jul 27;343(4):269-80. doi: 10.1056/NEJM200007273430407. No abstract available.
- Background: PubMed 16517585Sapey E, Stockley RA. COPD exacerbations . 2: aetiology. Thorax. 2006 Mar;61(3):250-8. doi: 10.1136/thx.2005.041822.
- Background: PubMed 19038881Sethi S, Murphy TF. Infection in the pathogenesis and course of chronic obstructive pulmonary disease. N Engl J Med. 2008 Nov 27;359(22):2355-65. doi: 10.1056/NEJMra0800353. No abstract available.
- Background: PubMed 20415983Mohan A, Chandra S, Agarwal D, Guleria R, Broor S, Gaur B, Pandey RM. Prevalence of viral infection detected by PCR and RT-PCR in patients with acute exacerbation of COPD: a systematic review. Respirology. 2010 Apr;15(3):536-42. doi: 10.1111/j.1440-1843.2010.01722.x.
- Background: PubMed 23695200Leuppi JD, Schuetz P, Bingisser R, Bodmer M, Briel M, Drescher T, Duerring U, Henzen C, Leibbrandt Y, Maier S, Miedinger D, Muller B, Scherr A, Schindler C, Stoeckli R, Viatte S, von Garnier C, Tamm M, Rutishauser J. Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial. JAMA. 2013 Jun 5;309(21):2223-31. doi: 10.1001/jama.2013.5023.
- Background: PubMed 6770731Albert RK, Martin TR, Lewis SW. Controlled clinical trial of methylprednisolone in patients with chronic bronchitis and acute respiratory insufficiency. Ann Intern Med. 1980 Jun;92(6):753-8. doi: 10.7326/0003-4819-92-6-753.
- Background: PubMed 2920584Emerman CL, Connors AF, Lukens TW, May ME, Effron D. A randomized controlled trial of methylprednisolone in the emergency treatment of acute exacerbations of COPD. Chest. 1989 Mar;95(3):563-7. doi: 10.1378/chest.95.3.563.
- Background: PubMed 8924134Bullard MJ, Liaw SJ, Tsai YH, Min HP. Early corticosteroid use in acute exacerbations of chronic airflow obstruction. Am J Emerg Med. 1996 Mar;14(2):139-43. doi: 10.1016/S0735-6757(96)90120-5.
- Background: PubMed 8756814Thompson WH, Nielson CP, Carvalho P, Charan NB, Crowley JJ. Controlled trial of oral prednisone in outpatients with acute COPD exacerbation. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):407-12. doi: 10.1164/ajrccm.154.2.8756814.
- 8\. The Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Joerg D. Leuppi, Prof. principal investigator
Kantonsspital Basleland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisone in people with Pulmonary Disease, Chronic Obstructive and Adverse Effect of Glucocorticoids and Synthetic Analogues, run by Prof. Dr. Jörg Leuppi at 1 site in Switzerland.
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 8 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: stopped early, as of the sponsor's last update on 12 Mar 2025. 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 Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment rate, motivation and engagement of participating GPs unfortunately declined over time, as well as the financial resources.). Results are not available in the source record.
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?
Time to next exacerbation (time frame: Six month follow-up period after index exacerbation.). 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 NCT02386735, which also lists 25 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 12 Mar 2025.