Chronic Obstructive Pulmonary DiseaseQvarCOPDNCT01141452
Real-life Effectiveness and Cost-effectiveness of Qvar Versus FP and BDP in the Management of COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Research in Real-Life Ltd at 1 site in United Kingdom.
Trial summary
The objective of this study is to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing chronic obstructive pulmonary disease (COPD) in primary care patients with evidence of COPD who either initiate inhaled corticosteroid (ICS) therapy, or have an increase in their ICS dose, as… 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?
- Extra-fine hydrofluoroalkane beclomethasone MDI, Chlorofluorocarbon beclomethasone metered dose inhaler and Fluticasone propionate metred dose inhaler
- How many people
- 815,377 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2001to Jul 2007
- Phase
- Observational
- 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
Study population: Primary care COPD patients who at an index prescription date either initiated ICS therapy as extrafine HFA-BDP, CFC-BDP or FP via MDI or had an increase in baseline BDP-equivalent ICS dose the index data as extrafine HFA-BDP, CFC-BDP or FP via MDI
Who may be able to join
- Aged ≥40 years at index prescription date
- COPD diagnosis:
- diagnostic code, and
- ≥2 prescriptions for COPD therapy in baseline year (at different points in time)
- For the ICS increase cohort (i.e. IPDA) ≥1 of these prescriptions must be for ICS therapy.
- Commence ICS therapy at any time (even if before COPD diagnosis is made)
Who cannot join
- A diagnostic read code for any other chronic respiratory disease (except asthma)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
General Practice Research Database
London, London, SW8 5NQ
About this study
Official title: Retrospective, Real-life Evaluation of the Effectiveness, Cost-effectiveness and Direct Healthcare Costs of Qvar Pressurised Metered-dose Inhaler (pMDI) Compared With Beclometasone Dipropionate pMDI and Fluticasone pMDI in the Management of Chronic Obstructive Pulmonary Disease (COPD) in a Representative UK Primary Care Patient Population
The objective of this study is to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing chronic obstructive pulmonary disease (COPD) in primary care patients with evidence of COPD who either initiate inhaled corticosteroid (ICS) therapy, or have an increase in their ICS dose, as hydrofluoroalkane (HFA) beclometasone dipropionate (BDP) (hereafter Qvar®), CFC-BDP (hereafter BDP) and fluticasone propionate (FP) via pressurised metered-dose inhalers.
Read the detailed description
Current asthma guidelines in the UK are underpinned by evidence derived from randomised controlled trials (RCTs). Although RCT data are considered the gold standard, patients recruited to asthma RCTs are estimated to represent less than 10% of the UK's asthma population. The poor representation of the asthma population is due to a number of factors, such as tightly-controlled inclusion criteria for RCTs. There is, therefore, a need for more representative RCTs and real-life observational studies to inform existing guidelines and help optimise asthma outcomes.
Short randomised trials have shown that Qvar is at least as effective as FP pMDI and as BDP pMDI at half the prescribed dose in patients with asthma. There is also evidence to suggest that, in adults, HFA formulation as used by Qvar (featuring BDP in solution rather than suspension) may achieve 10-fold higher deposition compared with CFC-BDP.4 Furthermore, deposition in the peripheral regions is higher compared with CFC-BDP and the fine-particle formulation also offers greater tolerance of poor co-ordination of breathing and inhaler actuation, resulting in lower oro-pharyngeal deposition compared with CFC-BDP.
Evidence of the efficacy of ICS monotherapy in COPD remains mixed at this time. While Qvar and ICS monotherapy use in the treatment of COPD is currently off-label, it occurs in clinical practice in two common scenarios:
- before a diagnosis of COPD is made
- unlicensed use as monotherapy, or in combination with long-acting bronchodilators
The study hypothesis, therefore, is that Qvar treatment in COPD may be associated with improved disease management and control (as assessed by effectiveness, cost-effectiveness and direct healthcare costs of managing COPD) compared with other commonly used ICS therapies, namely BPD and FP, by virtue of its improved deposition throughout the lungs and the small airways.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Extra-fine hydrofluoroalkane beclomethasone MDI, Chlorofluorocarbon beclomethasone metered dose inhaler, Fluticasone propionate metred dose inhaler, Hydrofluoroalkane beclomethasone metred dose inhaler, Chlorofluorocarbon beclomethasone dipropionate
- Keywords
- chronic obstructive pulmonary disease, inhaled corticosteroid, increase, initiate, exacerbations, treatment success
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-fine hydrofluoroalkane beclomethasone MDIDrug
Also called Qvar®
Step-up in baseline BDP-equivalent ICS dose
Chlorofluorocarbon beclomethasone metered dose inhalerDrug
Step-up in baseline BDP-equivalent ICS dose
Fluticasone propionate metred dose inhalerDrug
Step-up in baseline BDP-equivalent ICS dose
Fluticasone propionate metred dose inhalerDrug
Initiation of ICS therapy
Hydrofluoroalkane beclomethasone metred dose inhalerDrug
Also called Qvar®
Initiation of ICS therapy
Chlorofluorocarbon beclomethasone dipropionateDrug
Initiation of ICS therapy
| Study group | Role | What they receive |
|---|---|---|
| IPDA FP MDI | Patients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as fluticasone via metered dose inhaler Receives: Drug: Fluticasone propionate metred dose inhaler | |
| IPDA HFA-BDP MDI | Patients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as extra-fine hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler Receives: Drug: Extra-fine hydrofluoroalkane beclomethasone MDI | |
| IPDA CFC-BDP MDI | Patients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as chlorofluorocarbon beclomethasone dipropionate via metered dose inhaler Receives: Drug: Chlorofluorocarbon beclomethasone metered dose inhaler | |
| IPDI CFC-BDP MDI | Patients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as chlorofluorocarbon beclomethasone dipropionate via metered dose inhaler Receives: Drug: Chlorofluorocarbon beclomethasone dipropionate | |
| IPDI HFA-BDP MDI | Patients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler Receives: Drug: Hydrofluoroalkane beclomethasone metred dose inhaler | |
| IPDI FP MDI | Patients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as fluticasone propionate via metered dose inhaler Receives: Drug: Fluticasone propionate metred dose inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of exacerbations; exacerbation rate ratio; time to first after IPD
Where exacerbations are defined as:
- Unscheduled hospital admissions / A\&E attendances:*
- For COPD (definite code) and
- Lower respiratory tract infections (LRTI) treated with antibiotics
- Acute use of oral steroids
- Antibiotics use with a lower respiratory read code within a ±5-day window
Measured: Two-year outcome period
COPD treatment success
- No recorded hospital attendance for COPD or respiratory related events (i.e. with a lower respiratory read code), including:
- Admission
- A\&E attendance
- Out of hours attendance
- No exacerbations of COPD ("definite" plus "possible" prescriptions as defined above)
- No consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.
Measured: Two-year outcome period
Secondary outcomes (10)
COPD treatment success factoring in change in therapy
Defined as absence of:
- Exacerbations; and/or
- Increase in dose of inhaled steroid; and/or
- Change in delivery device, and/or
- Change in ICS
- Use of additional therapy not received in baseline year, split by:
- LABA
- Theophylline
- LTRAs.
Measured: Two-year outcome period
COPD treatment success factoring in change in therapy unrelated to cost savings
Defined as absence of:
- Exacerbations; and/or
- Increase in dose of inhaled steroid; and/or
- Use of additional therapy not received in baseline year, split by:
- LABA
- Theophylline
- LTRAs.
Measured: Two-year outcome period
Change in ICS dosing
Proportion of patients who:
- Remained on the same ICS (and/or combination therapy) throughout the outcome period
- Remained on the same ICS dose throughout the outcome period, but had another therapy added
- Received an ICS dose increase and / or therapy added to their ICS during the outcome period.
Measured: Two-year outcome period
Rate of hospitalisations
Where hospitalisations are defined as
- Admissions and A\&E coded as:
- lower respiratory-related, or
- for COPD
- Admissions and A\&E coded as:
- lower respiratory-related, or
- for COPD
- admission attendance occurring within a ±7 day window of an LRTI treated with antibiotics.
Measured: Two-year outcomes
SABA usage
Average SABA daily dose, categorised as: 0mcg, >0-100mcg, >100-200mcg, >200-400mcg, >400-800mcg, >800mcg.
Measured: Two-year outcome
Mortality
- Respiratory mortality
- All-cause mortality
Measured: Two-years
Incidence of pneumonia
- Unconfirmed (i.e. all unique patients with codes for pneumonia) AND
- Confirmed:
- chest X-ray within a month of a pneumonia diagnosis, or
- hospitalisation within a month of a pneumonia diagnosis
Measured: Two-year outcome
Incremental cost effectiveness ratio
Difference in costs (HFA-BDP the comparator) over difference in effectiveness (using primary outcome of exacerbations)
Measured: Two-year outcome
Cost of total healthcare treatment
Costs for each intervention:
- including ICS costs
- excluding ICS costs
Measured: Two-year outcome
Costs for COPD treatment
Costs of COPD treatment:
- including ICS costs
- excluding ICS costs
Measured: Two-year outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJan 2001
- Primary completionJun 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 815,377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research in Real-Life Ltd
- Sponsor type
- Research network
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Investigators
- David Price, Prof. MD, Principal investigator, Company DirectorAlison Chisholm, MSc, Study director, Research Project Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141452
- Sponsor's protocol ID
- BA5
- Acronym
- QvarCOPD
- Status last verified
- Mar 2011
- First submitted
- 9 Jun 2010
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Herland K, Akselsen JP, Skjonsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease? Respir Med. 2005 Jan;99(1):11-9. doi: 10.1016/j.rmed.2004.03.026.
PubMed 15672843Travers J, Marsh S, Caldwell B, Williams M, Aldington S, Weatherall M, Shirtcliffe P, Beasley R. External validity of randomized controlled trials in COPD. Respir Med. 2007 Jun;101(6):1313-20. doi: 10.1016/j.rmed.2006.10.011. Epub 2006 Nov 17.
PubMed 17113277Appleton SL, Adams RJ, Wilson DH, Taylor AW, Ruffin RE; North West Adelaide Cohort Health Study Team. Spirometric criteria for asthma: adding further evidence to the debate. J Allergy Clin Immunol. 2005 Nov;116(5):976-82. doi: 10.1016/j.jaci.2005.08.034.
PubMed 16275363Leach CL, Davidson PJ, Boudreau RJ. Improved airway targeting with the CFC-free HFA-beclomethasone metered-dose inhaler compared with CFC-beclomethasone. Eur Respir J. 1998 Dec;12(6):1346-53. doi: 10.1183/09031936.98.12061346.
PubMed 9877489Barber JA, Thompson SG. Analysis and interpretation of cost data in randomised controlled trials: review of published studies. BMJ. 1998 Oct 31;317(7167):1195-200. doi: 10.1136/bmj.317.7167.1195.
PubMed 9794854
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Real-life Evaluation of the Effectiveness, Cost-effectiveness and Direct Healthcare Costs of Qvar Pressurised Metered-dose Inhaler (pMDI) Compared With Beclometasone Dipropionate pMDI and Fluticasone pMDI in the Management of Chronic Obstructive Pulmonary Disease (COPD) in a Representative UK Primary Care Patient Population
- ClinicalTrials.gov ID
- NCT01141452
- Acronym / sponsor ID
- QvarCOPD / BA5
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, inhaled corticosteroid, increase, initiate, exacerbations, treatment success
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 815,377 participants (actual)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- Jan 2001
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 10 Jun 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 objective of this study is to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing chronic obstructive pulmonary disease (COPD) in primary care patients with evidence of COPD who either initiate inhaled corticosteroid (ICS) therapy, or have an increase in their ICS dose, as hydrofluoroalkane (HFA) beclometasone dipropionate (BDP) (hereafter Qvar®), CFC-BDP (hereafter BDP) and fluticasone propionate (FP) via pressurised metered-dose inhalers.
Detailed description
Current asthma guidelines in the UK are underpinned by evidence derived from randomised controlled trials (RCTs). Although RCT data are considered the gold standard, patients recruited to asthma RCTs are estimated to represent less than 10% of the UK's asthma population. The poor representation of the asthma population is due to a number of factors, such as tightly-controlled inclusion criteria for RCTs. There is, therefore, a need for more representative RCTs and real-life observational studies to inform existing guidelines and help optimise asthma outcomes.
Short randomised trials have shown that Qvar is at least as effective as FP pMDI and as BDP pMDI at half the prescribed dose in patients with asthma. There is also evidence to suggest that, in adults, HFA formulation as used by Qvar (featuring BDP in solution rather than suspension) may achieve 10-fold higher deposition compared with CFC-BDP.4 Furthermore, deposition in the peripheral regions is higher compared with CFC-BDP and the fine-particle formulation also offers greater tolerance of poor co-ordination of breathing and inhaler actuation, resulting in lower oro-pharyngeal deposition compared with CFC-BDP.
Evidence of the efficacy of ICS monotherapy in COPD remains mixed at this time. While Qvar and ICS monotherapy use in the treatment of COPD is currently off-label, it occurs in clinical practice in two common scenarios:
- before a diagnosis of COPD is made
- unlicensed use as monotherapy, or in combination with long-acting bronchodilators
The study hypothesis, therefore, is that Qvar treatment in COPD may be associated with improved disease management and control (as assessed by effectiveness, cost-effectiveness and direct healthcare costs of managing COPD) compared with other commonly used ICS therapies, namely BPD and FP, by virtue of its improved deposition throughout the lungs and the small airways.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| IPDA FP MDI | – | Drug: Fluticasone propionate metred dose inhalerPatients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as fluticasone via metered dose inhaler |
| IPDA HFA-BDP MDI | – | Drug: Extra-fine hydrofluoroalkane beclomethasone MDIPatients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as extra-fine hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler |
| IPDA CFC-BDP MDI | – | Drug: Chlorofluorocarbon beclomethasone metered dose inhalerPatients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as chlorofluorocarbon beclomethasone dipropionate via metered dose inhaler |
| IPDI CFC-BDP MDI | – | Drug: Chlorofluorocarbon beclomethasone dipropionatePatients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as chlorofluorocarbon beclomethasone dipropionate via metered dose inhaler |
| IPDI HFA-BDP MDI | – | Drug: Hydrofluoroalkane beclomethasone metred dose inhalerPatients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler |
| IPDI FP MDI | – | Drug: Fluticasone propionate metred dose inhalerPatients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as fluticasone propionate via metered dose inhaler |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care COPD patients who at an index prescription date either initiated ICS therapy as extrafine HFA-BDP, CFC-BDP or FP via MDI or had an increase in baseline BDP-equivalent ICS dose the index data as extrafine HFA-BDP, CFC-BDP or FP via MDI
Key inclusion criteria (6 listed)
- Aged ≥40 years at index prescription date
- COPD diagnosis:
Key exclusion criteria (1 listed)
- A diagnostic read code for any other chronic respiratory disease (except asthma)
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 |
|---|---|---|
| Extra-fine hydrofluoroalkane beclomethasone MDIAlso: Qvar®Step-up in baseline BDP-equivalent ICS dose | Drug | IPDA HFA-BDP MDI |
| Chlorofluorocarbon beclomethasone metered dose inhalerStep-up in baseline BDP-equivalent ICS dose | Drug | IPDA CFC-BDP MDI |
| Fluticasone propionate metred dose inhalerStep-up in baseline BDP-equivalent ICS dose | Drug | IPDA FP MDI |
| Fluticasone propionate metred dose inhalerInitiation of ICS therapy | Drug | IPDI FP MDI |
| Hydrofluoroalkane beclomethasone metred dose inhalerAlso: Qvar®Initiation of ICS therapy | Drug | IPDI HFA-BDP MDI |
| Chlorofluorocarbon beclomethasone dipropionateInitiation of ICS therapy | Drug | IPDI CFC-BDP MDI |
Primary outcome
Total number of exacerbations; exacerbation rate ratio; time to first after IPD
Time frame: Two-year outcome period
Where exacerbations are defined as: * Unscheduled hospital admissions / A\&E attendances:* * For COPD (definite code) and * Lower respiratory tract infections (LRTI) treated with antibiotics * Acute use of oral steroids * Antibiotics use with a lower respiratory read code within a ±5-day window
COPD treatment success
Time frame: Two-year outcome period
* No recorded hospital attendance for COPD or respiratory related events (i.e. with a lower respiratory read code), including: * Admission * A\&E attendance * Out of hours attendance * No exacerbations of COPD ("definite" plus "possible" prescriptions as defined above) * No consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.
10 secondary outcomes
COPD treatment success factoring in change in therapy
Time frame: Two-year outcome period
COPD treatment success factoring in change in therapy unrelated to cost savings
Time frame: Two-year outcome period
Change in ICS dosing
Time frame: Two-year outcome period
Rate of hospitalisations
Time frame: Two-year outcomes
SABA usage
Time frame: Two-year outcome
Mortality
Time frame: Two-years
Incidence of pneumonia
Time frame: Two-year outcome
Incremental cost effectiveness ratio
Time frame: Two-year outcome
Cost of total healthcare treatment
Time frame: Two-year outcome
Costs for COPD treatment
Time frame: Two-year outcome
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 8 Mar 2011.
- Background: PubMed 15672843Herland K, Akselsen JP, Skjonsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease? Respir Med. 2005 Jan;99(1):11-9. doi: 10.1016/j.rmed.2004.03.026.
- Background: PubMed 17113277Travers J, Marsh S, Caldwell B, Williams M, Aldington S, Weatherall M, Shirtcliffe P, Beasley R. External validity of randomized controlled trials in COPD. Respir Med. 2007 Jun;101(6):1313-20. doi: 10.1016/j.rmed.2006.10.011. Epub 2006 Nov 17.
- Background: PubMed 16275363Appleton SL, Adams RJ, Wilson DH, Taylor AW, Ruffin RE; North West Adelaide Cohort Health Study Team. Spirometric criteria for asthma: adding further evidence to the debate. J Allergy Clin Immunol. 2005 Nov;116(5):976-82. doi: 10.1016/j.jaci.2005.08.034.
- Background: PubMed 9877489Leach CL, Davidson PJ, Boudreau RJ. Improved airway targeting with the CFC-free HFA-beclomethasone metered-dose inhaler compared with CFC-beclomethasone. Eur Respir J. 1998 Dec;12(6):1346-53. doi: 10.1183/09031936.98.12061346.
- Background: PubMed 9794854Barber JA, Thompson SG. Analysis and interpretation of cost data in randomised controlled trials: review of published studies. BMJ. 1998 Oct 31;317(7167):1195-200. doi: 10.1136/bmj.317.7167.1195.
- Optimum Patient Care is the Research in Real Life's sister company (a social enterprise organisation)Link provided by the sponsor.
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.
David Price, Prof. MD principal investigator
Company Director
Alison Chisholm, MSc study director
Research Project Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Research in Real-Life Ltd 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 6 inclusion and 1 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 8 Mar 2011. 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. 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 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?
Total number of exacerbations; exacerbation rate ratio; time to first after IPD (time frame: Two-year outcome period). The study lists 2 primary outcomes in all. 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 NCT01141452, which also lists 5 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 8 Mar 2011.