Trial · NCT05948891
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of quality of life through CAT (COPD assessement tool) over 6 month period | Month 6 | To assess change in QoL using the CAT scale over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Primary endpoint is the proportion of patients achieving a ≥2-point reduction in CAT total score (MCID) at M6 compared to baseline. |
| Secondary | Mean change Quality of life through VQ11 questionnaire | Month 0, Month 3 and Month 6 | To assess change in QoL using the VQ11 scale over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is mean VQ11 total score and sub scores described at baseline, M3 and M6 |
| Secondary | Proportion of patients achieving a ≥2-point reduction in VQ11 total score | Month 0, Month 3 and Month 6 | To assess change in QoL using the VQ11 scale over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is the proportion of patients achieving a ≥2-point reduction in VQ11 total score (MCID) at M3 and M6 compared to baseline. |
| Secondary | Mean change in Dyspnoea throught "Dyspnea-12 questionnaire" | Month 0, Month 3 and Month 6 | To assess changes in dyspnoea using the Dyspnea-12 over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is D-12 total score and sub scores described at baseline, M3 and M6 |
| Secondary | Proportion of patients achieving a 3-point reduction in "Dyspnea-12" total score | Month 0, Month 3 and Month 6 | To assess changes in dyspnoea using the Dyspnea-12 over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is the proportion of patients achieving a 3-point reduction in D-12 total score (MCID) at M3 and M6 compared to baseline. |
| Secondary | Rate of moderate and severe exacerbations at M0, M3 and M6 through eCRF | Month 0, Month 3 and Month 6 | To describe the occurrence of moderate to severe exacerbations over a 6- month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device Endpoint is the proportion of patients with at least a moderate or severe exacerbation (overall and in each category), at baseline (in the previous 12 months), M3 and M6 |
| Secondary | Proportion of patients achieving an increase in physical activity throught the a connected device | Month 0, Month 3 and Month 6 | To assess changes in physical activity using a connected watch over a 6-month • Endpoint is the proportion of patients achieving an increase in physical activity (≥ 10%-increase in the mean daily number of step) at M3 and M6 compared to baseline. Baseline physical activity (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing watch over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device |
| Secondary | Mean daily number of steps throught the a connected device | Month 0, Month 3 and Month 6 | To assess changes in physical activity using a connected watch over a 6-month • Endpoints are the mean daily number of steps and the mean of number of steps during 7 days at M0, M3 and M6 Baseline physical activity (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing watch over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device |
| Secondary | Sleep quality throught the Pittsburgh questionnaire | Month 0, Month 3 and Month 6 | • Endpoints are the Pittsburgh questionnaire at M0, M3 and M6 Baseline physical activity (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing. |
| Secondary | Sleep quality throught the a connected device | Month 0, Month 3 and Month 6 | To assess changes in sleep quality using a connected device • Endpoints are the mean daily sleep time, the mean of sleep time and the mean daily number of awakenings during 7 days at M0, M3 and M6 Baseline sleep quality (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing. |
| Secondary | Treatment compliance at M3 and M6 through TAI (test inhaler adherence) questionnary | Month 3 and Month 6 | To assess treatment compliance with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is the description of treatment compliance global score at M3 and M6 for COPD using TAI |
| Secondary | Baseline description of sociodemographic data and medical data through eCRF | baseline | to describe COPD patient, disease and treatment characteristics at initiation of BDP/FF/G (88/5/9) in NEXThaler® device * Endpoints are description of sociodemographic (age, sex, weight, height, education level, occupation), medical data (risk factors exposure including tobacco, disease history) and lung function data (FEV1, FVC, RV, TLC) at baseline * Endpoints are description of comorbidities and associated treatment throughout the study at baseline * Endpoints are description of previous COPD-related treatment at baseline through eCRF |
| Secondary | Treatment tolerance throughout the study through eCRF | up to 24 weeks | To assess treatment tolerance in COPD patients treated with with BDP/FF/G (88/5/9) in NEXThaler® device To assess patient satisfaction with treatment in COPD patients treated with BDP/FF/GB NEXThaler® 88/5/9 |
| Other | Correlation between exacerbations occurrence and physical activity | Month 6 | To assess the association between exacerbations occurrence and physical activity changes Physical activity measured by a connected device over a 6-month follow-up |
| Other | Correlation between exacerbations occurrence and sleep quality | Month 6 | To assess the association between exacerbations occurrence sleep quality changes Sleep quality changes measured by a connected device over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device for COPD |
| Other | Correlation between QoL measured by VQ11 and the CAT through PROM | Month 0, Month 3 and Month 6 | To assess the correlation between QoL measured with the VQ11 and the CAT for COPD • Endpoints are value of the Pearson correlation test described at baseline, M3 and M6 |
| Other | Correlation between QoL measured with the VQ11 and Dyspnea-12 through PROM | Month 0, Month 3 and Month 6 | To assess the correlation between QoL measured with the VQ11 and Dyspnea-12 for COPD • Endpoints are value of the Pearson correlation test described at baseline, M3 and M6 |
| Other | Among patients with the connected device, assess the correlation of sleep quality when measured with connected device and with the Pittsburgh Sleep Quality Index | Month 0, Month 3 and Month 6 | Among COPD patients with the connected device, to assess the correlation of sleep quality when measured with connected device and with the Pittsburgh Sleep Quality Index • Endpoints are value of the Pearson correlation test described at baseline, M3 and M6 |
| Other | Dyspnoea with modified Medical Research Council (mMRC) | Month 0, Month 3 and Month 6 | Endpoint is mMRC total score described at baseline, M3 and M6 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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