A Phase 4 interventional study of Vilanterol / Umeclidinium (25/62.5 mcg) and Fluthicasone / Vilanterol / Umeclidinium (100/25/62.5 mcg) in COPD Bronchitis and Pollution Related Respiratory Disorder, sponsored by National Institute of Respiratory Diseases, Mexico. Recruiting at 1 site in Mexico. Open to female participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by National Institute of Respiratory Diseases, Mexico · Phase 4, Interventional, and Treatment
This phase IV randomized controlled clinical trial intend to compare the effect of three close standard inhaled triple therapies and one close standard inhaled double therapy on the small airway in patients with Chronic Obstructive Pulmonary Disease (COPD-B) and chronic bronchitis without obstruction (BCNO) exposed to wood smoke. The treatment phase duration is of 3 months. As primary outcome, the resistance change in post-bronchodilatator impulse oscilometry will me measure at 30 minutes, 2 hours, 4 hours, and 24 hours post first dose of the asigned medication, and then at 1 and 3 months of treatment. As secondary outcomes, change in respiratory symptoms and health related quality of life will be assess after 1 and 3 months of treatment.
Selection visit day -21 to -1: The diagnosis of COPD-B or BCNO will be verified. The inclusion criteria will be checked and it will be verified if there are any exclusion criteria (clinical record will be reviewed if necessary). The patient is invited to the study, will be given detailed information about it, and a copy of the informed consent for evaluation. If they agree to participate in the study, they will be asked to sign the consent in the indicated space, as well as two witnesses. If the patient does not have post-bronchodilator forced spirometry and a six-minute walk in the last 3 weeks, these tests will be performed in the COPD lung function laboratory. A symptom diary will be dispensed and training will be given on how to fill it out. The patient will be instructed to begin the washout time, which will be one week for long-acting bronchodilators (LAMA or LABA, or LAMA/LABA combination), and 3 weeks for inhaled steroids (or ICS/LABA, ICS/LAMA/LABA). During this period, patients will be able to use their rescue bronchodilator (SAMA, SABA, or combination) by schedule. They will be instructed in the identification of exacerbations and alarm symptoms and, if necessary, communicate with the principal investigator.
Randomization visit and initiation of treatment. (Visit 0, day 0): A complete patient history will be taken, with main emphasis on the recording of comorbidities and concomitant medication. Inclusion and exclusion criteria will be checked. The washout time of each bronchodilator will be confirmed, and once confirmed, baseline questionnaires will be performed: Measurement of dyspnea (mMRC scale) and health realated quality of life questionnaires (CAT and SGRQ). The history of exacerbations in the last 4 weeks will be verified. If the patient continue to meet the criteria, they will be selected and baseline respiratory function tests will begin: The tests will be performed between 7:00 to 8:00 AM in the following order: Exhaled fraction of nitric oxide (FeNO), impulse oscillometry, slow spirometry, forced spirometry, and simple plethysmography. The selection criteria will be confirmed and if they are a candidate, randomization will be carried out through the Redcap program. Patients will be assigned one of the four devices contemplated for the study. The first group will be assigned the device containing Vilanterol/Umeclidinium 25/62.5 mcg (Anoro) with a dose of one inhalation every 24 hours; the second group will be assigned the device containing Fluticasone/ Vilanterol/ Umeclidinium 100/25/62.5 mcg (Trelegy) with a dose of one inhalation every 24 hours; the third group will be assigned the device containing Beclomethasone/ Formoterol/ Glycopyrronium 100/6/12.5 mcg (Trimbow) with doses of two inhalations every 12 hours; the forth group will be assigned the device containing Budesonide/Formoterol/Glycopyrronium 160/4.8/7.2 mcg with doses of two inhalations every 12 hours. Each patient will be given a 100 μg salbutamol device as rescue medication.
Once the study medication is assigned, they will be instructed in technique and dosage, and a corresponding dose will be applied. A blood sample will be taken for a blood count and IgE test and Th2 and Th17 inflammatory profile cytokines. After 30 minutes of application of the study medication, impulse oscillometry, slow spirometry and forced spirometry will be performed. After 2 hours of application of study medication, impulse oscillometry, slow spirometry and forced spirometry will be performed. After 4 hours of application of study medication, impulse oscillometry, slow spirometry and forced spirometry will be performed. At the end of the respiratory function tests, the patient will be referred to the imaging service for tomography evaluation if it is not available with volumetry in the last year. Adverse events will be measured at baseline, for the safety outcome. The patient will be instructed in the use of the assigned medication, technique, frequency of use, as well as information and training on possible side effects. Visit 1 will be scheduled the next day without a window period.
Follow-up visit 1 (Visit 1, Day 1): Changes in respiratory symptoms, presence of adverse events, and use of concomitant medication will be questioned and documented. Symptom diary will be reviewed. It will be confirmed that the patient has not applied the morning dose of study medication. Dyspnea questionnaire (mMRC) and quality of life questionnaire (CAT) will be completed. Pulmonary function tests will be performed: FeNO, impulse oscillometry, slow spirometry, forced spirometry and simple plethysmography. Standard doses of SABA (400 mcg of salbutamol) will be applied and after 20 minutes post-bronchodilator tests of impulse oscillometry, slow spirometry and forced spirometry will be performed. The patient will be instructed in the technique of inhalation of study medication and a corresponding dose will be applied. Study medication will be provided for one month of treatment. A symptom diary will be provided and a follow-up visit 2 will be scheduled 30 days after the randomization visit.
Follow-up visit 2 (Visit 2, 30 days -2/+1 day): Exacerbations during the period, frequency of adverse events, newly diagnosed comorbidities and use of concomitant medication will be questioned and documented. Symptom diary will be reviewed. Devices dispensed at visit 1 will be reviewed to calculate adherence to treatment (≥80%). It will be confirmed that the patient has not applied the morning dose of study medication. Dyspnea questionnaire (mMRC), quality of life questionnaire (Saint George and CAT), and adherence to inhaled medication questionnaire (TAI) will be completed. Baseline pulmonary function tests will be performed: FeNO, impulse oscillometry, slow spirometry, forced spirometry and simple plethysmography. Short-acting bronchodilator (SABA) will be applied, the patient will be left to rest for 20 minutes. Post-bronchodilator tests will be initiated in the following order: impulse oscillometry, slow spirometry, forced spirometry. The patient will be instructed in the technique of inhalation of study medication and a corresponding dose will be applied. Study medication will be provided for two months of treatment. A symptom diary will be provided and a follow-up visit 3 will be scheduled 12 weeks after the randomization visit. Instructions for said visit will be given.
Follow-up visit 3 (Visit 3, 12 weeks -2/+1 day): Exacerbations during the period, frequency of adverse events, newly diagnosed comorbidities and use of concomitant medication will be questioned and documented. Symptom diary will be reviewed. Devices dispensed at visit 1 will be reviewed to calculate adherence to treatment (≥80%). It will be confirmed that the patient has not applied the morning dose of study medication. Dyspnea questionnaire (mMRC), quality of life questionnaire (Saint George and CAT), and adherence to inhaled medication questionnaire (TAI) will be completed. Baseline pulmonary function tests will be performed: FeNO, impulse oscillometry, slow spirometry, forced spirometry and simple plethysmography. Standard doses of SABA (400 mcg of salbutamol) will be applied and after 20 minutes post-bronchodilator tests of impulse oscillometry, slow spirometry and forced spirometry will be performed. Participation in the protocol will be terminated and monitoring by the NIRD Tobacco and COPD clinic will continue.
209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.
This study's planned enrollment of 128 is above the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.
Browse Bronchitis, Chronic studies →National Institute of Respiratory Diseases, Mexico is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Compared within Bronchitis, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pulmonary Disease, Chronic Obstructive. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of or chronic bronchitis without obstruction due to biomass smoke exposure:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vilanterol / Umeclidinium 25/62.5 mcg once daily for three months = ANORO® Fluthicasone / Vilanterol / Umeclidinium 100/25/62.5 mcg once daily for three months = TRELEGY® Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg; two inhalations twice daily for three months = TRIMBOW® Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg; two inhalations twice daily for three months= TRIXEO®
Drug: Vilanterol / Umeclidinium (25/62.5 mcg) · Drug: Fluthicasone / Vilanterol / Umeclidinium (100/25/62.5 mcg) · Drug: Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg · Drug: Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg
Vilanterol / Umeclidinium 25/62.5 mcg once daily for three months = ANORO® Fluthicasone / Vilanterol / Umeclidinium 100/25/62.5 mcg once daily for three months = TRELEGY® Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg; two inhalations twice daily for three months = TRIMBOW® Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg; two inhalations twice daily for three months= TRIXEO®
Drug: Vilanterol / Umeclidinium (25/62.5 mcg) · Drug: Fluthicasone / Vilanterol / Umeclidinium (100/25/62.5 mcg) · Drug: Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg · Drug: Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg
Drug pages: Vilanterol · GSK573719
One inhalation daily from Ellipta device for three months
Also known as: ANORO
Drug pages: Fluticasone furoate · GSK573719 · Vilanterol
One inhalation daily from Ellipta device for three months
Also known as: TRELEGY
Two inhalations twice daily form pMDI device for three months
Also known as: TRIMBOW
Two inhalations twice daily form pMDI device for three months
Also known as: TRIXEO
Change in impulse oscillometry
To quantify the change in impulse oscillometry (post-bronchodilator) change in total resistance measured in percentage change from baseline change R5-R20 and/or AX for the patients who used Vilanterol / Umeclidinium 25/62.5 mcg once daily = ANORO®; Fluthicasone / Vilanterol / Umeclidinium 100/25/62.5 mcg once daily= TRELEGY®; Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg; two inhalations twice daily = TRIMBOW®; and Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg two inhalations twice daily= TRIXEO®.
Time frame: 3 months
Change of resistences in impulse oscillometry
Quantify the change in R5, R20, R5-R20 \[kPa/(L/s)\]
Time frame: 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months
Change of resistences in impulse oscillometry
Quantify the change in Ax \[kPa/L\]
Time frame: 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months
Change of total resistances in pletismography
Change in total resistances (kPa\*s/L), measured by plethysmography.
Time frame: 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months
Chance in lung function in spirometry
Change in FEV1, and FVC, both in liters.
Time frame: 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months
Chance in lung function in spirometry
Change in FEV1, and FVC, both percentage of predicted
Time frame: 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months
Chance in FEF25-75 in spirometry
Change in FEF25-75 (L/s)
Time frame: 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months
Chance in MMEF(L/s) in spirometry
Change in MMEF(L/s)
Time frame: 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months
Adherence assesment
Quantify adherence to treatment according to the type of inhaler.
Time frame: 3 months
Change in Fractional exhaled nitric oxide
Change in exhaled fraction of nitric oxide measured by parts per billion.
Time frame: 3 months
Change in Chronic Obstructive Pulmonary Disease Assesment Test
Change in quality of life in Chronic Obstructive Pulmonary Disease Assesment Test score
Time frame: 3 months
Change in Saint George Respiratory Questionnaire
Change in quality of life in the Saint George respiratory questionnaire scores
Time frame: 3 months
Change in dypsnea by modified Medical Research Council score
Change in dyspnea score measured by the modified Medical Research Council test
Time frame: 3 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The data will be collected on the redCap platform and may be shared in Excel CSV format upon request after the results are published.
Supporting information: Study protocol, Statistical analysis plan
Time frame: The IPD data will be available for sharing after the results are published. The data will me available for one year.
Access criteria: The information may be requested by researchers who wish to carry out a meta-analysis. The main author will evaluate the applications for sharing the data.
Started Nov 2023 (actual). Primary completion is estimated for Jan 2025, 14 months after the start.
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Studies of the drugs tested here: Vilanterol · GSK573719 · Fluticasone furoate
National Institute of Respiratory Diseases, Mexico