Clinical trial NCT05218564: Air as a Placebo: Increasing the Respiratory Performance of People With COPD Through Simple Expectations of Improvement
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Placebo
Oxygen therapy
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2022-02-01
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Metres covered during 6 Minute Walking Test (6MWT)
timeFrame: 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:
measure: Feeling of fatigue, as measured by the Fatigue Severity Scale (FSS)
timeFrame: 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
measure: VAS Dyspnoea, measured by the British Medical Research Council's Modified Questionnaire (mMRC)
timeFrame: 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
measure: Saturation (SpO2)
timeFrame: Change from baseline at 3':30'' and at 6':00'' of the 6 Minute Walking Test (6MWT)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi
Study officials:
References:
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