Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05183841 |
| Other study ID # |
3008.886 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 14, 2022 |
| Est. completion date |
November 2025 |
Study information
| Verified date |
December 2023 |
| Source |
University of Sao Paulo General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The bronchodilators (BD) have been widely used in bronchiectasis (BCE) therapeutic and have
been shown to be effective in improving exercise capacity in patients with chronic
obstructive pulmonary disease and asthma. However the BD effect on the exercise capacity of
patients with BCE is poorly known. Besides, the respiratory mechanics pattern of the patients
with BCE is not known nor its association with their physical activity level (PAL).
Therefore, the hypothesis of this study is that BD are effective in improving exercise
capacity of patients with BCE. The authors also propose to characterize the respiratory
mechanics of the patients with BCE and to evaluate their PAL and its association with quality
of life, as secondary aims.
Description:
This is a randomized, double-blind, crossover, placebo-controlled trial. Forty clinically
stable patients with bronchiectasis (BCE), all sexes, 18 to 59 years, will be evaluated in
two non-consecutive days. On the first day, anamnesis, anthropometric evaluation and lung
function will be performed, followed by: Quality of Life Questionnaire-Bronchiectasis, Saint
George questionnaire, modified Medical Research Council scale and social and economic status.
Then, a cardiopulmonary exercise test (CPET) will be performed and after a rest period, a
bronchodilator (BD) or placebo randomization will precede a constant load exercise test
(CLET) with the respiratory mechanics assessment (OEP). Spirometry will be performed pre and
post BD/placebo. Finally, the accelerometer will be coupled to the patient for 7 consecutive
days, aiming to assess the PAL. On the second day, after at least one-week washout, the
accelerometer will be collected and the patient will repeat the CLET with the respiratory
mechanics assessment, at the opposite condition to the randomization. The randomization
sequence will be generated by computer, and put in sealed and opaque envelopes by a volunteer
not involved in the study. The BD or placebo will be administered by a volunteer not involved
in the study, according to the randomization. The evaluator will not have access to
information on which intervention (BD or placebo) was given prior to each CLET. A paired
(anthropometric and social and economic status) healthy control group will be assessed by
spirometry, CPET, and CLET and OEP, for comparing respiratory mechanics. In addition the
participants will also use an accelerometer for 7 consecutive days. Data of endurance time
from CLET, respiratory mechanics from OEP, dyspnea and vital signs will be assessed before
and after both BD and placebo CLET. Data about onset of BCE, comorbidities and BCE medication
will be collected from the patient's medical record. Data normality will be tested by
Kolmogorov-Smirnov. Data comparison will be performed by t test or Wilcoxon and the
association by Pearson or Spearman. Categorical data will be analyzed by qui-square test or
Fischer. The significance level will be set to 5% for all tests.
