NCT01425801 is a Phase 2 clinical trial of LAS100977 0.313 μg in Asthma, sponsored by AstraZeneca.

Who is sponsoring NCT01425801?

NCT01425801 is sponsored by AstraZeneca.

What drugs are being tested in NCT01425801?

Interventions in NCT01425801: LAS100977 0.313 μg, LAS100977 0.625 μg, LAS100977 1.25 μg, LAS100977 2.5 μg, Salbutamol 400 μg, Salbutamol placebo, LAS100977 placebo.

Is NCT01425801 still recruiting?

NCT01425801 is currently completed. Last updated 8 May 2018.

Are results published for NCT01425801?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-05-08 · How we verify

NCT01425801

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.

Completed Phase 2 Results posted Last updated 8 May 2018

What this trial tests

Phase 2 trial testing LAS100977 0.313 μg in Asthma in 62 participants. Completed in 1 February 2012.

Timeline

1 August 2011

Primary endpoint
1 February 2012

1 February 2012

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	62
Start date	1 August 2011
Primary completion	1 February 2012
Estimated completion	1 February 2012
Sites	9 locations across United Kingdom, Germany

Drugs / interventions tested

LAS100977 0.313 μg — full drug profile →
LAS100977 0.625 μg — full drug profile →
LAS100977 1.25 μg — full drug profile →
LAS100977 2.5 μg — full drug profile →
Salbutamol 400 μg
Salbutamol placebo
LAS100977 placebo — full drug profile →

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 70, any sex, with Asthma. 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 Peak Forced Expiratory Volume in One Second (FEV1) Primary · Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose

Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.

Group	Value	95% CI
Placebo	0.202	± 0.045
LAS100977 0.313 μg	0.477	± 0.045
LAS100977 0.625 μg	0.524	± 0.045
LAS100977 1.25 μg	0.573	± 0.045
LAS100977 2.5 μg	0.608	± 0.045
Salbutamol 400 μg	0.555	± 0.045

Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) Secondary · Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose

Group	Value	95% CI
Placebo	7.555	± 1.655
LAS100977 0.313 μg	18.282	± 1.651
LAS100977 0.625 μg	20.212	± 1.651
LAS100977 1.25 μg	21.809	± 1.651
LAS100977 2.5 μg	23.077	± 1.650
Salbutamol 400 μg	21.374	± 1.658

Peak Forced Expiratory Volume in One Second (FEV1) Secondary · +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose

The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.

Group	Value	95% CI
Placebo	2.855	± 0.045
LAS100977 0.313 μg	3.129	± 0.045
LAS100977 0.625 μg	3.177	± 0.045
LAS100977 1.25 μg	3.225	± 0.045
LAS100977 2.5 μg	3.260	± 0.045
Salbutamol 400 μg	3.207	± 0.045

Time to Peak Forced Expiratory Volume in One Second (FEV1) Secondary · +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose

The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.

Group	Value	95% CI
Placebo	2.3	± 1.3
LAS100977 0.313 μg	2.6	± 1.3
LAS100977 0.625 μg	3.0	± 1.1
LAS100977 1.25 μg	3.1	± 0.9
LAS100977 2.5 μg	3.0	± 1.1
Salbutamol 400 μg	1.1	± 0.8

Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1) Secondary · Baseline and +23 h and +24 h post-dose

Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected

Group	Value	95% CI
Placebo	-0.054	± 0.039
LAS100977 0.313 μg	0.166	± 0.039
LAS100977 0.625 μg	0.205	± 0.039
LAS100977 1.25 μg	0.278	± 0.039
LAS100977 2.5 μg	0.346	± 0.039
Salbutamol 400 μg	-0.076	± 0.039

Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1 Secondary · Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h

FEV1 was normalized to baseline. Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

Group	Value	95% CI
Placebo	0.007	± 0.039
LAS100977 0.313 μg	0.282	± 0.039
LAS100977 0.625 μg	0.321	± 0.038
LAS100977 1.25 μg	0.390	± 0.038
LAS100977 2.5 μg	0.446	± 0.039
Salbutamol 400 μg	0.100	± 0.039

Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint Secondary · Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h

Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

0.25 hr

Group	Value	95% CI
Placebo	2.696	± 0.030
LAS100977 0.313 μg	2.863	± 0.030
LAS100977 0.625 μg	2.886	± 0.030
LAS100977 1.25 μg	2.934	± 0.030
LAS100977 2.5 μg	3.007	± 0.030
Salbutamol 400 μg	3.106	± 0.030

1 hr

Group	Value	95% CI
Placebo	2.719	± 0.037
LAS100977 0.313 μg	3.000	± 0.037
LAS100977 0.625 μg	3.025	± 0.037
LAS100977 1.25 μg	3.098	± 0.037
LAS100977 2.5 μg	3.133	± 0.037
Salbutamol 400 μg	3.147	± 0.037

2 hr

Group	Value	95% CI
Placebo	2.746	± 0.039
LAS100977 0.313 μg	3.034	± 0.038
LAS100977 0.625 μg	3.081	± 0.038
LAS100977 1.25 μg	3.136	± 0.038
LAS100977 2.5 μg	3.188	± 0.039
Salbutamol 400 μg	3.123	± 0.039

3 hr

Group	Value	95% CI
Placebo	2.771	± 0.041
LAS100977 0.313 μg	3.069	± 0.041
LAS100977 0.625 μg	3.102	± 0.041
LAS100977 1.25 μg	3.190	± 0.041
LAS100977 2.5 μg	3.196	± 0.041
Salbutamol 400 μg	3.040	± 0.041

4 hr

Group	Value	95% CI
Placebo	2.774	± 0.044
LAS100977 0.313 μg	3.058	± 0.044
LAS100977 0.625 μg	3.124	± 0.044
LAS100977 1.25 μg	3.167	± 0.044
LAS100977 2.5 μg	3.211	± 0.044
Salbutamol 400 μg	2.937	± 0.044

6 hr

Group	Value	95% CI
Placebo	2.722	± 0.038
LAS100977 0.313 μg	3.008	± 0.038
LAS100977 0.625 μg	3.087	± 0.038
LAS100977 1.25 μg	3.157	± 0.038
LAS100977 2.5 μg	3.194	± 0.038
Salbutamol 400 μg	2.812	± 0.038

8 hr

Group	Value	95% CI
Placebo	2.715	± 0.040
LAS100977 0.313 μg	3.033	± 0.039
LAS100977 0.625 μg	3.062	± 0.039
LAS100977 1.25 μg	3.139	± 0.039
LAS100977 2.5 μg	3.180	± 0.039
Salbutamol 400 μg	2.772	± 0.039

12 hr

Group	Value	95% CI
Placebo	2.659	± 0.044
LAS100977 0.313 μg	2.943	± 0.043
LAS100977 0.625 μg	2.980	± 0.043
LAS100977 1.25 μg	3.035	± 0.043
LAS100977 2.5 μg	3.111	± 0.043
Salbutamol 400 μg	2.669	± 0.044

Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint Secondary · Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h

Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.

0.25 hr

Group	Value	95% CI
Placebo	0.048	± 0.030
LAS100977 0.313 μg	0.214	± 0.030
LAS100977 0.625 μg	0.237	± 0.030
LAS100977 1.25 μg	0.285	± 0.030
LAS100977 2.5 μg	0.358	± 0.030
Salbutamol 400 μg	0.457	± 0.030

0.5 hr

Group	Value	95% CI
Placebo	0.071	± 0.034
LAS100977 0.313 μg	0.304	± 0.033
LAS100977 0.625 μg	0.319	± 0.033
LAS100977 1.25 μg	0.381	± 0.033
LAS100977 2.5 μg	0.437	± 0.033
Salbutamol 400 μg	0.490	± 0.034

1 hr

Group	Value	95% CI
Placebo	0.067	± 0.037
LAS100977 0.313 μg	0.348	± 0.037
LAS100977 0.625 μg	0.373	± 0.037
LAS100977 1.25 μg	0.446	± 0.037
LAS100977 2.5 μg	0.481	± 0.037
Salbutamol 400 μg	0.495	± 0.037

2 hr

Group	Value	95% CI
Placebo	0.094	± 0.039
LAS100977 0.313 μg	0.382	± 0.038
LAS100977 0.625 μg	0.429	± 0.038
LAS100977 1.25 μg	0.484	± 0.038
LAS100977 2.5 μg	0.536	± 0.039
Salbutamol 400 μg	0.471	± 0.039

3 hr

Group	Value	95% CI
Placebo	0.119	± 0.041
LAS100977 0.313 μg	0.416	± 0.041
LAS100977 0.625 μg	0.450	± 0.041
LAS100977 1.25 μg	0.537	± 0.041
LAS100977 2.5 μg	0.543	± 0.041
Salbutamol 400 μg	0.388	± 0.041

4 hr

Group	Value	95% CI
Placebo	0.121	± 0.044
LAS100977 0.313 μg	0.406	± 0.044
LAS100977 0.625 μg	0.471	± 0.044
LAS100977 1.25 μg	0.515	± 0.044
LAS100977 2.5 μg	0.558	± 0.044
Salbutamol 400 μg	0.284	± 0.044

6 hr

Group	Value	95% CI
Placebo	0.067	± 0.038
LAS100977 0.313 μg	0.353	± 0.038
LAS100977 0.625 μg	0.432	± 0.038
LAS100977 1.25 μg	0.501	± 0.038
LAS100977 2.5 μg	0.539	± 0.038
Salbutamol 400 μg	0.157	± 0.038

8 hr

Group	Value	95% CI
Placebo	0.056	± 0.040
LAS100977 0.313 μg	0.374	± 0.039
LAS100977 0.625 μg	0.403	± 0.039
LAS100977 1.25 μg	0.480	± 0.039
LAS100977 2.5 μg	0.521	± 0.039
Salbutamol 400 μg	0.113	± 0.039

Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint Secondary · Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h

Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.

0.25 hr

Group	Value	95% CI
Placebo	1.519	± 1.090
LAS100977 0.313 μg	8.325	± 1.084
LAS100977 0.625 μg	8.846	± 1.084
LAS100977 1.25 μg	10.789	± 1.084
LAS100977 2.5 μg	13.511	± 1.081
Salbutamol 400 μg	17.744	± 1.098

0.5 hr

Group	Value	95% CI
Placebo	2.449	± 1.205
LAS100977 0.313 μg	11.757	± 1.199
LAS100977 0.625 μg	12.006	± 1.199
LAS100977 1.25 μg	14.362	± 1.199
LAS100977 2.5 μg	16.715	± 1.196
Salbutamol 400 μg	18.806	± 12.209

1 hr

Group	Value	95% CI
Placebo	2.407	± 1.356
LAS100977 0.313 μg	13.452	± 1.350
LAS100977 0.625 μg	14.307	± 1.350
LAS100977 1.25 μg	16.927	± 1.350
LAS100977 2.5 μg	18.336	± 1.352
Salbutamol 400 μg	19.085	± 1.360

2 hr

Group	Value	95% CI
Placebo	3.520	± 1.434
LAS100977 0.313 μg	14.741	± 1.427
LAS100977 0.625 μg	16.371	± 1.428
LAS100977 1.25 μg	18.509	± 1.428
LAS100977 2.5 μg	20.226	± 1.430
Salbutamol 400 μg	17.755	± 1.438

3 hr

Group	Value	95% CI
Placebo	4.435	± 1.479
LAS100977 0.313 μg	15.965	± 1.472
LAS100977 0.625 μg	17.190	± 1.472
LAS100977 1.25 μg	20.357	± 1.477
LAS100977 2.5 μg	20.550	± 1.470
Salbutamol 400 μg	14.537	± 1.484

4 hr

Group	Value	95% CI
Placebo	4.288	± 1.596
LAS100977 0.313 μg	15.400	± 1.589
LAS100977 0.625 μg	17.960	± 1.590
LAS100977 1.25 μg	19.454	± 1.590
LAS100977 2.5 μg	21.155	± 1.587
Salbutamol 400 μg	10.608	± 1.600

6 hr

Group	Value	95% CI
Placebo	2.682	± 1.439
LAS100977 0.313 μg	13.661	± 1.424
LAS100977 0.625 μg	16.490	± 1.425
LAS100977 1.25 μg	19.080	± 1.425
LAS100977 2.5 μg	20.612	± 1.421
Salbutamol 400 μg	5.796	± 1.438

8 hr

Group	Value	95% CI
Placebo	2.752	± 1.505
LAS100977 0.313 μg	14.118	± 1.482
LAS100977 0.625 μg	15.128	± 1.482
LAS100977 1.25 μg	18.199	± 1.482
LAS100977 2.5 μg	19.733	± 1.478
Salbutamol 400 μg	4.493	± 1.497

Change From Baseline in Peak Forced Vital Capacity (FVC) Secondary · Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose

Group	Value	95% CI
Placebo	0.222	± 0.034
LAS100977 0.313 μg	0.317	± 0.034
LAS100977 0.625 μg	0.329	± 0.034
LAS100977 1.25 μg	0.361	± 0.034
LAS100977 2.5 μg	0.380	± 0.034
Salbutamol 400 μg	0.361	± 0.034

Peak Forced Vital Capacity (FVC) Secondary · +15 min, +30 min, +1 h, +2 h, +3 h, +4 h

The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

Group	Value	95% CI
Placebo	4.483	± 0.034
LAS100977 0.313 μg	4.578	± 0.034
LAS100977 0.625 μg	4.590	± 0.034
LAS100977 1.25 μg	4.622	± 0.034
LAS100977 2.5 μg	4.641	± 0.034
Salbutamol 400 μg	4.622	± 0.034

Time to Peak Forced Vital Capacity (FVC) Secondary · +15 min, +30 min, +1 h, +2 h, +3 h, +4 h

The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.

Group	Value	95% CI
Placebo	2.1	± 1.4
LAS100977 0.313 μg	1.8	± 1.4
LAS100977 0.625 μg	2.3	± 1.4
LAS100977 1.25 μg	2.1	± 1.2
LAS100977 2.5 μg	2.2	± 1.4
Salbutamol 400 μg	1.5	± 1.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 14 (±2) days after last intake of investigational medicinal product. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/59 (0%)

Deaths: —

LAS100977 0.313 μg

Serious: 0/60 (0%)

Deaths: —

LAS100977 0.625 μg

Serious: 0/60 (0%)

Deaths: —

LAS100977 1.25 μg

Serious: 0/60 (0%)

Deaths: —

LAS100977 2.5 μg

Serious: 0/61 (0%)

Deaths: —

Salbutamol 400 μg

Serious: 0/62 (0%)

Deaths: —

Other adverse events (2 terms — click to expand)

Reaction	System	Placebo	LAS100977 0.313 μg	LAS100977 0.625 μg	LAS100977 1.25 μg	LAS100977 2.5 μg	Salbutamol 400 μg
Headache	Nervous system disorders	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT01425801 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Mechanisms, Pathophysiology and Currently Proposed Treatments of Chronic Obstructive Pulmonary Disease.
Rodrigues SO, Cunha CMCD, Soares GMV, Silva PL, et al · · 2021 · cited 61× · PMID 34681202 · DOI 10.3390/ph14100979
A dose-ranging study of the bronchodilator effects of abediterol (LAS100977), a long-acting β2-adrenergic agonist, in asthma; a Phase II, randomized study.
Singh D, Pujol H, Ribera A, Seoane B, et al · · 2014 · cited 10× · PMID 25398689 · DOI 10.1186/1471-2466-14-176

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01425801 (US National Library of Medicine, public domain)
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: 8 May 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/NCT01425801.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01425801

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Asthma

Other AstraZeneca trials

Verify against primary sources