Trial · NCT07133880
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference Between the Values of Area Under the Response Curve for Inspiratory Capacity (IC) | From baseline (Visit 2, Week 2) through study completion (Visit 3, Week 12) | Difference between the values of area under the response curve for inspiratory capacity (IC) from baseline through six hours (AUC IC 0-6h) after inhalation of LAMA/LABA combination with a nebulizer versus a DPI OR Proportion of participants achieving improvement of \>2 points in their CAT score compared to baseline OR Proportion of participants achieving reduction of 4 points in SGRQ score compared to baseline |
| Secondary | Percentage change in Residual Volume (RV) from baseline after inhalation of LAMA/LABA combination with a nebulizer versus a DPI | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
| Secondary | Percentage change in Total Lung Capacity (TLC) from baseline after inhalation of LAMA/LABA combination with a nebulizer versus a DPI | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
| Secondary | Percentage change in airway resistance (Raw) from baseline after inhalation of LAMA/LABA combination with a nebulizer versus a DPI | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
| Secondary | Maximum percentage change in inspiratory capacity between 0 and 6 hours after LAMA/LABA combination with a nebulizer versus a DPI | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
| Secondary | Maximum percentage change in RV between 0 and 6 hours after LAMA/LABA combination | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
| Secondary | Maximum Percentage Change in Airway Resistance (Raw) between 0 and 6 hours after LAMA/LABA | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
| Secondary | Correlation of peak inspiratory flow rate with peak IC change from baseline | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
| Secondary | Comparison of CAT scores in patients receiving medications with DPI vs nebulizer | From baseline (Visit 2, Week 2) through study completion (Visit 3, Week 12) | |
| Secondary | Comparison of SGRQ scores in patients receiving medications with DPI vs nebulizer | At baseline (Visit 2, Week 2), and at study completion (Visit 3, Week 12) | |
| Secondary | Change in TDI in patients receiving medications with DPI vs nebulizer | Measured at Week 4 (Phone Visit 1), Week 8 (Phone Visit 2), and Week 12 (Study Visit 3) | |
| Secondary | Change in CAT scores in patients receiving medications with DPI vs nebulizer | From baseline (Visit 2, Week 2) through study completion (Visit 3, Week 12) | |
| Secondary | Change in SGRQ scores in patients receiving medications with DPI vs nebulizer | Measured at study visit 2 at week 2 and study completion visit 3 at week 12 | |
| Secondary | Correlation of CAT with LF and LH change (inspiratory capacity and residual volume change) with patient-reported outcomes including the SGRQ and the TDI | Baseline (Visit 2) through Study Completion (Visit 3 / Week 12) | |
| Secondary | Correlation of LH with patient-reported outcomes including scores from the CAT, SGRQ and TDI | Baseline (Visit 2) through Study Completion (Visit 3 / Week 12) |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT07133880/registered