Chronic Obstructive Pulmonary DiseasePhase 4NCT02209974
Effects of Inhaled Corticosteroids in the Systemic Inflammation Induced by Exercise in Patients With COPD
A Phase 4 study testing Fluticasone in people with Chronic Obstructive Pulmonary Disease, run by Hospital Son Llatzer at 1 site in Spain.
Trial summary
Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is controversial. Read more about this study
- Who is it for?
- Ages 58 to 72 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Fluticasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2004to Nov 2009
- 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 58 to 72 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ex-smokers (> 10 packets-year) with moderate-severe COPD patients
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inhaled Corticosteroids do Not Modify the Systemic Inflammation Induced by Exercise in Patients With Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is controversial.
Read the detailed description
Physical exercise produces a systemic inflammatory response, both in the healthy individual and in the COPD patient (Rabinovitch et al ERJ 2003; van Helvoort et al Respir Med 2005; Davidson WJ et al. J Appl Physiol). Nevertheless, although it has been described that some of the systemic biomarkers related with COPD (Protein C-Reactive (PCR), interleukin [IL]-8) are associated with a lower tolerance to exercise in COPD patients (García-Río et al. Respir Res 2010), the role of IC on systemic inflammation triggered by exercise in COPD patients remains unknown.
This study explores the hypothesis that the inflammatory response induced by exercise in COPD patients could be with IC treatment.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Fluticasone, Inhaled Placebo
- Keywords
- emphysema, CRP, interleukin-8, dynamic hyperinflation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluticasoneDrug
Also called Inhaled Corticosteroids
Administration of inhaled corticosteroids (fluticasone, 0.5 mg) each 12 hours to 8 of the 16 COPD patients versus placebo.
Inhaled PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Placebo | Placebo comparator | Inhaled placebo administered to healthy (n=7) and to a half (n=8) of COPD patients Receives: Drug: Inhaled Placebo |
| Inhaled corticosteroids (Fluticasone, 0.5 mg) | Experimental | Inhaled corticosteroids administered to the other half (n=8) of COPD patients Receives: Drug: Fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in response to exercise between healthy and COPD patients
16 COPD patients were compared with 7 healthy, sedentary and nonsmoker controls. All of them carried out an incremental cycle exercise test (ICET) limited by symptoms.
1 month later, ICET was repeated only by COPD patients.
Venous blood samples were obtained at rest and during peak exercise.
Anthropometric, functional and response characteristics to exercise:
Age, years
BMI, m2.kg-1
FEV1/FVC, %
FEV1, % reference
Peak charge, watts
VO2 peak, mL.min-1
Respiratory quotient
VE peak, L.min-1
Fc peak, lpm
Lactic acid peak, mmol.L-1
SaO2 basal, %
SaO2 peak, %
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startFeb 2004
- Primary completionNov 2009
- Study completionNov 2009
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Son Llatzer
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica, Hospital Son Espases, Spanish Research Center for Respiratory Diseases, Hospital Clinic of Barcelona, Fundació d'investigació Sanitària de les Illes Balears
- Responsible party
- Principal investigator, Antonia Fuster, Hospital Son Llatzer
- Investigators
- Antonia Fuster, PhD Medicine, Principal investigator, Hospital Son LlatzerJaume Sauleda, PhD Medicine, Study chair, Hospital Son EspasesCatalina Balaguer, Medicine, Study chair, Hospital Son EspasesBernardí Barceló, PhD Medicine, Study chair, Hospital Son EspasesAngel Rios, Nursing, Study chair, FISIB Fundació Investigació de les Illes BalearsAmanda Iglesias, Biology, Study chair, FISIB Fundació Investigació de les Illes BalearsAina Noguera, Medicine, Study chair, Hospital Son EspasesBernat Togores, Medicine, Study chair, Hospital Son Espases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209974
- Sponsor's protocol ID
- IC-COPD-2014
- Status last verified
- Aug 2014
- First submitted
- 23 Jul 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Corticosteroids do Not Modify the Systemic Inflammation Induced by Exercise in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02209974
- Acronym / sponsor ID
- IC-COPD-2014
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- emphysema, CRP, interleukin-8, dynamic hyperinflation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hospital Son LlatzerUniversity, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica, Hospital Son Espases, Spanish Research Center for Respiratory Diseases, Hospital Clinic of Barcelona, Fundació d'investigació Sanitària de les Illes Balears
- Study start
- Feb 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 6 Aug 2014 (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.
Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is controversial.
Detailed description
Physical exercise produces a systemic inflammatory response, both in the healthy individual and in the COPD patient (Rabinovitch et al ERJ 2003; van Helvoort et al Respir Med 2005; Davidson WJ et al. J Appl Physiol). Nevertheless, although it has been described that some of the systemic biomarkers related with COPD (Protein C-Reactive (PCR), interleukin [IL]-8) are associated with a lower tolerance to exercise in COPD patients (García-Río et al. Respir Res 2010), the role of IC on systemic inflammation triggered by exercise in COPD patients remains unknown.
This study explores the hypothesis that the inflammatory response induced by exercise in COPD patients could be with IC treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Placebo | Placebo comparator | Drug: Inhaled PlaceboInhaled placebo administered to healthy (n=7) and to a half (n=8) of COPD patients |
| Inhaled corticosteroids (Fluticasone, 0.5 mg) | Experimental | Drug: FluticasoneInhaled corticosteroids administered to the other half (n=8) of COPD patients |
Who may qualify
- Ages
- 58 to 72 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ex-smokers (> 10 packets-year) with moderate-severe COPD patients
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FluticasoneAlso: Inhaled CorticosteroidsAdministration of inhaled corticosteroids (fluticasone, 0.5 mg) each 12 hours to 8 of the 16 COPD patients versus placebo. | Drug | Inhaled corticosteroids (Fluticasone, 0.5 mg) |
| Inhaled Placebo | Drug | Inhaled Placebo |
Primary outcome
Differences in response to exercise between healthy and COPD patients
Time frame: 1 month
16 COPD patients were compared with 7 healthy, sedentary and nonsmoker controls. All of them carried out an incremental cycle exercise test (ICET) limited by symptoms. 1 month later, ICET was repeated only by COPD patients. Venous blood samples were obtained at rest and during peak exercise. Anthropometric, functional and response characteristics to exercise: Age, years BMI, m2.kg-1 FEV1/FVC, % FEV1, % reference Peak charge, watts VO2 peak, mL.min-1 Respiratory quotient VE peak, L.min-1 Fc peak, lpm Lactic acid peak, mmol.L-1 SaO2 basal, % SaO2 peak, %
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 6 Aug 2014.
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.
Antonia Fuster, PhD Medicine principal investigator
Hospital Son Llatzer
Jaume Sauleda, PhD Medicine study chair
Hospital Son Espases
Catalina Balaguer, Medicine study chair
Hospital Son Espases
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 Fluticasone in people with Chronic Obstructive Pulmonary Disease, run by Hospital Son Llatzer at 1 site in Spain.
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 1 inclusion and 0 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 6 Aug 2014. 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 Spain. 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 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?
Differences in response to exercise between healthy and COPD patients (time frame: 1 month). 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 6 Aug 2014.