Chronic Obstructive Pulmonary DiseaseNCT05218564
Air as a Placebo: Increasing the Respiratory Performance of People With COPD Through Simple Expectations of Improvement
A study testing Oxygen Therapy and Compressed Medical Air in people with Chronic Obstructive Pulmonary Disease, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
COPD (Chronic Obstructive Pulmonary Disease) is a disease of the respiratory system characterised by irreversible airway obstruction of varying severity. The disease (known as COPD, Chronic Obstructive Pulmonary Disease) is progressive and is associated with a state of chronic inflammation of the lung tissue, which… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Oxygen Therapy and Compressed Medical Air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- 19 Feb 2020to 31 Dec 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who voluntarily agree to participate in the study;
- Subjects with moderate-grade Chronic Obstructive Pulmonary Disease (COPD) (GOLD 2-50% ≤ FEV1 <80% of predicted) according to GOLD criteria;
- Subjects undergoing treatment with oxygen therapy and non-smokers;
- Ex-smokers
- Outpatients and inpatients
Who cannot join
- Refusal of Informed Consent
- Severe cognitive impairment, detected by administration of the Mini Mental Status Examination Test (MMSE)
- Pregnancy
- Patients with oncological or psychiatric pathologies
- Main immunodepression
Trial locations and contacts
1 site in 1 country.
Eleonora Volpato, PhD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi
Milan, 20148
Paolo Banfi, MD, 0240308812 ext. 0039, pabanfi@dongnocchi.it
Eleonora Volpato, PhD, 0240308812 ext. 0039, evolpato@dongnocchi.it
About this study
Official title: Air as a Placebo: Increasing the Respiratory Performance of People With COPD Through Simple Expectations of Improvement. An Experimental, Randomised, Two-arm, Counterbalanced Study With Three Data Collection Sessions.
COPD (Chronic Obstructive Pulmonary Disease) is a disease of the respiratory system characterised by irreversible airway obstruction of varying severity. The disease (known as COPD, Chronic Obstructive Pulmonary Disease) is progressive and is associated with a state of chronic inflammation of the lung tissue, which leads to a real remodelling of the bronchi causing a significant reduction in airway flow. Among the possible treatments, while the placebo is considered as an inert treatment, lacking any intrinsic therapeutic properties, there is evidence in the literature that not all placebos are equivalent and some are more effective than others, as for example in the case of migraine or osteoarthritis. The differences found between different types of placebos (e.g. oral, subcutaneous, intra-articular...) indicate that placebos are not inert but rather consist of multiple psychosocial elements that are part of the ritual of the therapeutic act. This is also the context for the studies by Lacasse et al. (for the International Nocturnal Oxygen (INOX) Research Group et al., 2017) and Jarosh et al., who investigated the effects of oxygen therapy both during sleep and during the course of daily life, studying its influences through the use of placebo in patients suffering from hypoxemia. However, in the literature, there are no studies investigating the role of oxygen (O2) during the performance of a test such as the Walking Test, otherwise known as the 6 Minute Walking Test (6MWT) compared with a placebo in patients with Chronic Obstructive Pulmonary Disease (COPD), nor whether the use of the latter would lead to comparable results.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Oxygen Therapy, Compressed Medical Air
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Placebo, Oxygen therapy
- 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.
Oxygen TherapyDrug
During the 6 Minute Walking Test (6MWT), the participant will be required to walk as fast as possible on a flat, straight surface on the ward (e.g. corridor) in six minutes, including as many breaks as he/she deems necessary. The performance of this test will be monitored continuously by a Respiratory Physiotherapist and will include the presence of a Physician, who will be ready to assist as needed. The sequence of use of compressed medical air and oxygen used during the 6MWT in the first group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen). The sequence of the second group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen).
Compressed Medical AirOther
Also called Placebo
During the 6 Minute Walking Test (6MWT), the participant will be required to walk as fast as possible on a flat, straight surface on the ward (e.g. corridor) in six minutes, including as many breaks as he/she deems necessary. The performance of this test will be monitored continuously by a Respiratory Physiotherapist and will include the presence of a Physician, who will be ready to assist as needed. The sequence of use of compressed medical air and oxygen used during the 6MWT in the first group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen). The sequence of the second group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen).
| Study group | Role | What they receive |
|---|---|---|
| Group 1, consisting of participants with COPD and usually using O2 | Experimental | In this group, in addition to the standard care, the participant undergoes the 6 Minute Walking Test (6MWT) using compressed medical air (RA) cylinders, believing that there is oxygen (O2) inside the cylinder. The same, then, in addition to the standard care, is subjected to the execution of the 6 Minute Walking Test (6MWT), thanks to the use of cylinders of Oxygen (O2), believing that inside the cylinder there is Oxygen (O2). The sequence of this group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen). Receives: Other: Compressed Medical Air |
| Group 2, consisting of participants with COPD and usually not using O2 | Placebo comparator | In this group, in addition to standard care, the participant is given the 6 Minute Walking Test (6MWT) using oxygen (O2) cylinders, believing that there is oxygen (O2) inside the cylinder. Next, the participant undergoes the 6 Minute Walking Test (6MWT), using compressed medical air (RA) cylinders, believing that there is oxygen (O2) inside the cylinder. The sequence of this group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen). Receives: Drug: Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metres covered during 6 Minute Walking Test (6MWT)
Distance in metres during the 6 Minute Walking Test (6MWT)
Measured: Changes from baseline at the metres covered after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
Secondary outcomes (3)
Feeling of fatigue, as measured by the Fatigue Severity Scale (FSS)
Feeling of fatigue, as measured by the Fatigue Severity Scale (FSS). The items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity.
Measured: Changes from baseline at the FSS after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
VAS Dyspnoea, measured by the British Medical Research Council's Modified Questionnaire (mMRC)
VAS Dyspnoea, measured by the British Medical Research Council's Modified Questionnaire (mMRC). The mMRC breathlessness scale ranges from grade 0 to 4.
Measured: Change from baseline at the dyspnoea after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
Saturation (SpO2)
Saturation (SpO2)
Measured: Change from baseline at 3':30'' and at 6':00'' of the 6 Minute Walking Test (6MWT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start19 Feb 2020
- Primary completion30 Mar 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Responsible party
- Principal investigator, Paolo Banfi, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218564
- Sponsor's protocol ID
- FDG_Placebo_COPD
- Status last verified
- Jan 2022
- First submitted
- 28 Dec 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bannuru RR, McAlindon TE, Sullivan MC, Wong JB, Kent DM, Schmid CH. Effectiveness and Implications of Alternative Placebo Treatments: A Systematic Review and Network Meta-analysis of Osteoarthritis Trials. Ann Intern Med. 2015 Sep 1;163(5):365-72. doi: 10.7326/M15-0623.
PubMed 26215539Barnes PJ. Chronic obstructive pulmonary disease: a growing but neglected global epidemic. PLoS Med. 2007 May;4(5):e112. doi: 10.1371/journal.pmed.0040112.
PubMed 17503959Benedetti F. Placebo and the new physiology of the doctor-patient relationship. Physiol Rev. 2013 Jul;93(3):1207-46. doi: 10.1152/physrev.00043.2012.
PubMed 23899563Benedetti F. Placebo effects: from the neurobiological paradigm to translational implications. Neuron. 2014 Nov 5;84(3):623-37. doi: 10.1016/j.neuron.2014.10.023. Epub 2014 Nov 5.
PubMed 25442940Benedetti F, Dogue S. Different Placebos, Different Mechanisms, Different Outcomes: Lessons for Clinical Trials. PLoS One. 2015 Nov 4;10(11):e0140967. doi: 10.1371/journal.pone.0140967. eCollection 2015.
PubMed 26536471Benedetti F, Durando J, Giudetti L, Pampallona A, Vighetti S. High-altitude headache: the effects of real vs sham oxygen administration. Pain. 2015 Nov;156(11):2326-2336. doi: 10.1097/j.pain.0000000000000288.
PubMed 26164587Benedetti F, Durando J, Vighetti S. Nocebo and placebo modulation of hypobaric hypoxia headache involves the cyclooxygenase-prostaglandins pathway. Pain. 2014 May;155(5):921-928. doi: 10.1016/j.pain.2014.01.016. Epub 2014 Jan 21.
PubMed 24462931Berry MJ, Rejeski WJ, Adair NE, Zaccaro D. Exercise rehabilitation and chronic obstructive pulmonary disease stage. Am J Respir Crit Care Med. 1999 Oct;160(4):1248-53. doi: 10.1164/ajrccm.160.4.9901014.
PubMed 10508815Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
PubMed 10377201Blinderman CD, Homel P, Billings JA, Tennstedt S, Portenoy RK. Symptom distress and quality of life in patients with advanced chronic obstructive pulmonary disease. J Pain Symptom Manage. 2009 Jul;38(1):115-23. doi: 10.1016/j.jpainsymman.2008.07.006. Epub 2009 Feb 20.
PubMed 19232893de Craen AJ, Tijssen JG, de Gans J, Kleijnen J. Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos. J Neurol. 2000 Mar;247(3):183-8. doi: 10.1007/s004150050560.
PubMed 10787112Dowson CA, Kuijer RG, Mulder RT. Anxiety and self-management behaviour in chronic obstructive pulmonary disease: what has been learned? Chron Respir Dis. 2004;1(4):213-20. doi: 10.1191/1479972304cd032rs.
PubMed 16281648Lacasse Y, Bernard S, Series F, Nguyen VH, Bourbeau J, Aaron S, Maltais F; International Nocturnal Oxygen (INOX) Research Group. Multi-center, randomized, placebo-controlled trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease: a study protocol for the INOX trial. BMC Pulm Med. 2017 Jan 9;17(1):8. doi: 10.1186/s12890-016-0343-9.
PubMed 28069009Jarosch I, Gloeckl R, Damm E, Schwedhelm AL, Buhrow D, Jerrentrup A, Spruit MA, Kenn K. Short-term Effects of Supplemental Oxygen on 6-Min Walk Test Outcomes in Patients With COPD: A Randomized, Placebo-Controlled, Single-blind, Crossover Trial. Chest. 2017 Apr;151(4):795-803. doi: 10.1016/j.chest.2016.11.044. Epub 2016 Dec 8.
PubMed 27940278Kong J, Spaeth R, Cook A, Kirsch I, Claggett B, Vangel M, Gollub RL, Smoller JW, Kaptchuk TJ. Are all placebo effects equal? Placebo pills, sham acupuncture, cue conditioning and their association. PLoS One. 2013 Jul 31;8(7):e67485. doi: 10.1371/journal.pone.0067485. Print 2013.
PubMed 23935833
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air as a Placebo: Increasing the Respiratory Performance of People With COPD Through Simple Expectations of Improvement. An Experimental, Randomised, Two-arm, Counterbalanced Study With Three Data Collection Sessions.
- ClinicalTrials.gov ID
- NCT05218564
- Acronym / sponsor ID
- FDG_Placebo_COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Placebo, Oxygen therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Feb 2022 (actual)
- 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.
COPD (Chronic Obstructive Pulmonary Disease) is a disease of the respiratory system characterised by irreversible airway obstruction of varying severity. The disease (known as COPD, Chronic Obstructive Pulmonary Disease) is progressive and is associated with a state of chronic inflammation of the lung tissue, which leads to a real remodelling of the bronchi causing a significant reduction in airway flow. Among the possible treatments, while the placebo is considered as an inert treatment, lacking any intrinsic therapeutic properties, there is evidence in the literature that not all placebos are equivalent and some are more effective than others, as for example in the case of migraine or osteoarthritis. The differences found between different types of placebos (e.g. oral, subcutaneous, intra-articular...) indicate that placebos are not inert but rather consist of multiple psychosocial elements that are part of the ritual of the therapeutic act. This is also the context for the studies by Lacasse et al. (for the International Nocturnal Oxygen (INOX) Research Group et al., 2017) and Jarosh et al., who investigated the effects of oxygen therapy both during sleep and during the course of daily life, studying its influences through the use of placebo in patients suffering from hypoxemia. However, in the literature, there are no studies investigating the role of oxygen (O2) during the performance of a test such as the Walking Test, otherwise known as the 6 Minute Walking Test (6MWT) compared with a placebo in patients with Chronic Obstructive Pulmonary Disease (COPD), nor whether the use of the latter would lead to comparable results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1, consisting of participants with COPD and usually using O2 | Experimental | Other: Compressed Medical AirIn this group, in addition to the standard care, the participant undergoes the 6 Minute Walking Test (6MWT) using compressed medical air (RA) cylinders, believing that there is oxygen (O2) inside the cylinder. The same, then, in addition to the standard care, is subjected to the execution of the 6 Minute Walking Test (6MWT), thanks to the use of cylinders of Oxygen (O2), believing that inside the cylinder there is Oxygen (O2). The sequence of this group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen). |
| Group 2, consisting of participants with COPD and usually not using O2 | Placebo comparator | Drug: Oxygen TherapyIn this group, in addition to standard care, the participant is given the 6 Minute Walking Test (6MWT) using oxygen (O2) cylinders, believing that there is oxygen (O2) inside the cylinder. Next, the participant undergoes the 6 Minute Walking Test (6MWT), using compressed medical air (RA) cylinders, believing that there is oxygen (O2) inside the cylinder. The sequence of this group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who voluntarily agree to participate in the study;
- Subjects with moderate-grade Chronic Obstructive Pulmonary Disease (COPD) (GOLD 2-50% ≤ FEV1 <80% of predicted) according to GOLD criteria;
- Subjects undergoing treatment with oxygen therapy and non-smokers;
- Ex-smokers
- Outpatients and inpatients
Key exclusion criteria (5 listed)
- Refusal of Informed Consent
- Severe cognitive impairment, detected by administration of the Mini Mental Status Examination Test (MMSE)
- Pregnancy
- Patients with oncological or psychiatric pathologies
- Main immunodepression
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 |
|---|---|---|
| Oxygen TherapyDuring the 6 Minute Walking Test (6MWT), the participant will be required to walk as fast as possible on a flat, straight surface on the ward (e.g. corridor) in six minutes, including as many breaks as he/she deems necessary. The performance of this test will be monitored continuously by a Respiratory Physiotherapist and will include the presence of a Physician, who will be ready to assist as needed. The sequence of use of compressed medical air and oxygen used during the 6MWT in the first group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen). The sequence of the second group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen). | Drug | Group 2, consisting of participants with COPD and usually not using O2 |
| Compressed Medical AirAlso: PlaceboDuring the 6 Minute Walking Test (6MWT), the participant will be required to walk as fast as possible on a flat, straight surface on the ward (e.g. corridor) in six minutes, including as many breaks as he/she deems necessary. The performance of this test will be monitored continuously by a Respiratory Physiotherapist and will include the presence of a Physician, who will be ready to assist as needed. The sequence of use of compressed medical air and oxygen used during the 6MWT in the first group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen). The sequence of the second group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen). | Other | Group 1, consisting of participants with COPD and usually using O2 |
Primary outcome
Metres covered during 6 Minute Walking Test (6MWT)
Time frame: Changes from baseline at the metres covered after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
Distance in metres during the 6 Minute Walking Test (6MWT)
3 secondary outcomes
Feeling of fatigue, as measured by the Fatigue Severity Scale (FSS)
Time frame: Changes from baseline at the FSS after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
VAS Dyspnoea, measured by the British Medical Research Council's Modified Questionnaire (mMRC)
Time frame: Change from baseline at the dyspnoea after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
Saturation (SpO2)
Time frame: Change from baseline at 3':30'' and at 6':00'' of the 6 Minute Walking Test (6MWT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Results publication: PubMed 26215539Bannuru RR, McAlindon TE, Sullivan MC, Wong JB, Kent DM, Schmid CH. Effectiveness and Implications of Alternative Placebo Treatments: A Systematic Review and Network Meta-analysis of Osteoarthritis Trials. Ann Intern Med. 2015 Sep 1;163(5):365-72. doi: 10.7326/M15-0623.
- Results publication: PubMed 17503959Barnes PJ. Chronic obstructive pulmonary disease: a growing but neglected global epidemic. PLoS Med. 2007 May;4(5):e112. doi: 10.1371/journal.pmed.0040112.
- Results publication: PubMed 23899563Benedetti F. Placebo and the new physiology of the doctor-patient relationship. Physiol Rev. 2013 Jul;93(3):1207-46. doi: 10.1152/physrev.00043.2012.
- Results publication: PubMed 25442940Benedetti F. Placebo effects: from the neurobiological paradigm to translational implications. Neuron. 2014 Nov 5;84(3):623-37. doi: 10.1016/j.neuron.2014.10.023. Epub 2014 Nov 5.
- Results publication: PubMed 26536471Benedetti F, Dogue S. Different Placebos, Different Mechanisms, Different Outcomes: Lessons for Clinical Trials. PLoS One. 2015 Nov 4;10(11):e0140967. doi: 10.1371/journal.pone.0140967. eCollection 2015.
- Results publication: PubMed 26164587Benedetti F, Durando J, Giudetti L, Pampallona A, Vighetti S. High-altitude headache: the effects of real vs sham oxygen administration. Pain. 2015 Nov;156(11):2326-2336. doi: 10.1097/j.pain.0000000000000288.
- Results publication: PubMed 24462931Benedetti F, Durando J, Vighetti S. Nocebo and placebo modulation of hypobaric hypoxia headache involves the cyclooxygenase-prostaglandins pathway. Pain. 2014 May;155(5):921-928. doi: 10.1016/j.pain.2014.01.016. Epub 2014 Jan 21.
- Results publication: PubMed 10508815Berry MJ, Rejeski WJ, Adair NE, Zaccaro D. Exercise rehabilitation and chronic obstructive pulmonary disease stage. Am J Respir Crit Care Med. 1999 Oct;160(4):1248-53. doi: 10.1164/ajrccm.160.4.9901014.
- Results publication: PubMed 10377201Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
- Results publication: PubMed 19232893Blinderman CD, Homel P, Billings JA, Tennstedt S, Portenoy RK. Symptom distress and quality of life in patients with advanced chronic obstructive pulmonary disease. J Pain Symptom Manage. 2009 Jul;38(1):115-23. doi: 10.1016/j.jpainsymman.2008.07.006. Epub 2009 Feb 20.
- Results publication: PubMed 10787112de Craen AJ, Tijssen JG, de Gans J, Kleijnen J. Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos. J Neurol. 2000 Mar;247(3):183-8. doi: 10.1007/s004150050560.
- Results publication: PubMed 16281648Dowson CA, Kuijer RG, Mulder RT. Anxiety and self-management behaviour in chronic obstructive pulmonary disease: what has been learned? Chron Respir Dis. 2004;1(4):213-20. doi: 10.1191/1479972304cd032rs.
- 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.
Eleonora Volpato, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen Therapy and Compressed Medical Air in people with Chronic Obstructive Pulmonary Disease, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Feb 2022. 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 Italy. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Banfi, MD (00390239703341, pabanfi@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metres covered during 6 Minute Walking Test (6MWT) (time frame: Changes from baseline at the metres covered after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half). 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 NCT05218564, which also lists 16 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 1 Feb 2022.