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

Don Carlo Gnocchi Onlus Foundation

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Oxygen Therapy; Other: Compressed Medical Air

Study type: Interventional

Funder types: Other

Identifiers

NCT05218564

FDG_Placebo_COPD

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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102 participants in 2 patient groups, including a placebo group

Group 1, consisting of participants with COPD and usually using O2

Experimental group

Description:

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).

Treatment:

Other: Compressed Medical Air

Group 2, consisting of participants with COPD and usually not using O2

Placebo Comparator group

Description:

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).

Treatment:

Drug: Oxygen Therapy