Trial · NCT02991859
Registered outcomes50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 50
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis | 12 hours post last dose on Day 7 | The percentage fall in FEV1 was calculated using highest FEV1 (post saline) minus highest FEV1 (post AMP) divided by highest FEV1 (post saline)\*100 where highest FEV1 (post saline) is the highest value of two FEV1 measurements at 60 and 180 seconds after the saline control, highest FEV1 (post AMP) is the highest value of the two FEV1 measurements at 60 and 180 seconds after the dose of AMP. Results are presented treatment wise. The analysis method was a 3 parameter Emax model with log 2 transformed AMP PC20 as the outcome variable, assuming common Emax across FF, FP and BUD, and with an unstructured variance-covariance matrix. Mean and 95% Confidence Interval (CI) presented are predicted estimate. |
| Primary | Cortisol Suppression 0-24 Hours Weighted Mean-Dose Response Analysis | Pre-dose PM dose on Day 6 to pre-dose PM dose Day 7 | Blood samples for measurement of plasma cortisol were collected at given time point. The weighted means were derived by calculating the area under the curve (AUC) over the 0-24-hour period using the trapezoidal rule, and then dividing it by the actual time interval. Results are presented treatment wise. Mean and 95% CI presented are predicted estimate. The analysis method was an inhibitory exponential power-law model with log e transformed cortisol as the outcome variable, assuming 100% inhibition at highest doses. |
| Primary | Theraputic Index of FF | 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7 | Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter\[nmol/L\]) divided by Dose at which 80% of the maximum effect is reached (ED80) for AMP PC20 for FF 25 mcg, FF 100 mcg, FF 200 mcg, FF 400 mcg, FF 800 mcg. Theraputic index has been presented. Only those participants with data available at the specified time points were analyzed. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively. |
| Primary | Theraputic Index of FP | 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7 | Therapeutic Index was calculated by Dose at which 20% of the maximum effect is reached (ED20) for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter\[nmol/L\]) divided by ED80 for AMP PC20 for FP 50 mcg, FP 200 mcg, FP 500 mcg, FP 1000 mcg, FP 2000 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively. |
| Primary | Theraputic Index of BUD | 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7 | Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter\[nmol/L\]) divided by ED80 for AMP PC20 for BUD 100 mcg, BUD 400 mcg, BUD 800 mcg, BUD 1600 mcg, BUD 3200 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively. |
| Secondary | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) | Up to Week 18 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that at any dose results in death, Is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Results are presented treatment wise. |
| Secondary | Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1 | Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in period 1 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). |
| Secondary | PEFR as a Measure of Safety and Tolerability of Placebo in Period 2 | Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in Period 2 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1 | Day 2,3,4,5,6,7 PM in period 1 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2 | Day 2,3,4,5,6,7 PM in period 2 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1 | Day 8,9,10,11,12,13,14 PM in period 1 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2 | Day 8,9,10,11,12,13,14 PM in period 2 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1 | Day 15,16,17,18,19,20,21 PM in period 1 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2 | Day 15,16,17,18,19,20 PM, Day 21 AM and PM in period 2 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1 | Days 22,23,24,25,26,27,28 PM in period 1 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2 | Days 22,23,24,25,26,27,28 PM in period 2 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1 | Days 29,30,31,32,33,34,35 PM in period 1 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2 | Day 29,30,31,32,33,34,35 PM in period 2 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1 | Day 2,3,4,5,6,7 PM in period 1 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2 | Day 2,3,4,5,6,7 AM and PM in period 2 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
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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