Air as a Placebo: Increasing the Respiratory Performance of People With COPD Through Simple Expectations of Improvement

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Oxygen Therapy
* Other: Compressed Medical Air


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1, consisting of participants with COPD and usually using O2<br>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). | Other: Compressed Medical Air<br>* 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).<br>* Other names: Placebo;|
| Placebo Comparator: Group 2, consisting of participants with COPD and usually not using O2<br>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). | Drug: Oxygen Therapy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metres covered during 6 Minute Walking Test (6MWT) | Distance in metres during the 6 Minute Walking Test (6MWT) | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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) | Change from baseline at 3':30'' and at 6':00'' of the 6 Minute Walking Test (6MWT) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, COPD, Placebo, Oxygen therapy