Adults 40 to 130, any sex, with Chronic Obstructive Pulmonary Disease - COPD. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on TreatmentPrimary· Day 7: 30 min, 1 to 4 hours, 6 hours, 9 hours and 12 hours post-dose
To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate(20 μg).
Pre-dose spirometry was performed before the morning daily dose at Day 1 and Day 7 of each treatment period. Two sets of measurements were performed during the hour preceding the scheduled morning study drug administration, allowing approximately 30 minutes between them.
Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.
Group
Value
95% CI
Formoterol Fumarate 6 μg
0.108
0.073 – 0.143
Formoterol Fumarate (FF) 12 μg
0.117
0.082 – 0.151
Formoterol Fumarate (FF) 24 μg
0.161
0.125 – 0.197
Perforomist 20 μg
0.122
0.087 – 0.156
Placebo (Lactose Monohydrate)
0.000
-0.055 – 0.054
Change From Baseline in FEV1 AUC0-6/6h at Day 1 on TreatmentSecondary· Day 1: zero time to 6 hours post-dose
To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg and 40 μg). 6-hour serial spirometry was performed at Day 1 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose.
Group
Value
95% CI
Formoterol Fumarate 6 μg
0.111
0.077 – 0.145
Formoterol Fumarate (FF) 12 μg
0.148
0.115 – 0.182
Formoterol Fumarate (FF) 24 μg
0.205
0.171 – 0.239
Perforomist 20 μg
0.195
0.162 – 0.229
Perforomist 40 μg
0.246
0.212 – 0.280
Placebo (Lactose Monohydrate)
-0.019
-0.063 – 0.025
Change From Baseline in FEV1 AUC0-6/6h at Day 7 on TreatmentSecondary· Day 7: zero time to 6 hours post-dose
To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). 6-hour serial spirometry was performed at Day 7 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation
Group
Value
95% CI
Formoterol Fumarate 6 μg
0.166
0.127 – 0.205
Formoterol Fumarate (FF) 12 μg
0.177
0.139 – 0.215
Formoterol Fumarate (FF) 24 μg
0.225
0.186 – 0.265
Perforomist 20 μg
0.186
0.147 – 0.225
Placebo (Lactose Monohydrate)
0.007
-0.050 – 0.064
Change From Baseline in Morning Pre-dose (Trough) FEV1 at Day 7 on TreatmentSecondary· At baseline and Day 7
To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). Trough value was defined as the mean of the 2 pre-dose measurements on Day 7. If 1 of the 2 measurements was missing, the non-missing measurement was used as the trough value.
Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.
Group
Value
95% CI
Formoterol Fumarate 6 μg
0.077
0.044 – 0.109
Formoterol Fumarate (FF) 12 μg
0.067
0.035 – 0.098
Formoterol Fumarate (FF) 24 μg
0.102
0.069 – 0.135
Perforomist 20 μg
0.061
0.029 – 0.092
Placebo (Lactose Monohydrate)
0.002
-0.059 – 0.063
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time of signature of informed consent throughout the treatment period and including the follow-up period (i.e. 2 weeks after the last IP)..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Formoterol Fumarate 6 μg
Serious: 1/107 (1%)
Deaths: 0/107
Formoterol Fumarate (FF) 12 μg
Serious: 2/121 (2%)
Deaths: 1/121
Formoterol Fumarate (FF) 24 μg
Serious: 0/105 (0%)
Deaths: 0/105
Perforomist 20 μg
Serious: 0/118 (0%)
Deaths: 0/118
Perforomist 40 μg
Serious: 1/109 (1%)
Deaths: 0/109
Placebo (Lactose Monohydrate)
Serious: 1/38 (3%)
Deaths: 0/38
Serious adverse events (5 terms)
Reaction
System
Formoterol Fumarate 6 μg
Formoterol Fumarate (FF) 1…
Formoterol Fumarate (FF) 2…
Perforomist 20 μg
Perforomist 40 μg
Placebo (Lactose Monohydra…
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea
· not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential
· not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis
· NA
· not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec
· Phase 4
· not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 7 February 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02796651.