AsthmaPhase 2NCT01425801
Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.
A Phase 2 study testing LAS100977 0.313 μg, LAS100977 0.625 μg and LAS100977 1.25 μg in people with Asthma, run by AstraZeneca at 9 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- LAS100977 0.313 μg, LAS100977 0.625 μg and LAS100977 1.25 μg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 1 Aug 2011to 1 Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female patients aged 18-70 years (both included).
- Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for at least 6 months prior to screening.
- Screening FEV1 value of 60% < FEV1 ≤ 85% of the predicted normal value.
- FEV1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline value after inhalation of 400µg (four inhalations) of salbutamol.
- Pre-dose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation.
- Patients on a stable dose and regimen
Who cannot join
- Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years.
- Patients diagnosed with COPD.
- Recent Respiratory tract infections within 6 weeks before Screening Visit.
- Intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit.
- Clinically significant respiratory conditions.
- Clinically significant cardiovascular conditions.
Show all 9Show fewer
- Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
- Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
- Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany7 sites
Almirall Investigational Sites#6
Berlin, 10117
Almirall Investigational Sites#4
Berlin, 14050
Almirall Investigational Sites#1
Berlin, 14057
Almirall Investigational Sites#3
Frankfurt, 60596
Almirall Investigational Sites#2
Großhansdorf, 22927
Almirall Investigational Sites#8
Hamburg, 20249
Almirall Investigational Sites#5
Wiesbaden, 65187
United Kingdom2 sites
Almirall Investigational Sites#2
London, W1G 8HT
Almirall Investigational Sites#1
Manchester, M3 9QZ
About this study
Official title: A Phase IIa, Randomised, Single Dose, Double-blind, Double-dummy, 6 Way Complete Cross-over, Placebo Controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of 4 Doses of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Persistent Asthma.
The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma.
- Conditions
- Asthma
- Being tested
- LAS100977 0.313 μg, LAS100977 0.625 μg, LAS100977 1.25 μg, LAS100977 2.5 μg, Salbutamol 400 μg
- Keywords
- COPD
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAS100977 0.313 μgDrug
Dry powder inhalation, once-daily, single-dose
LAS100977 0.625 μgDrug
Dry powder inhalation, once-daily, single-dose
LAS100977 1.25 μgDrug
Dry powder inhalation, once-daily, single-dose
LAS100977 2.5 μgDrug
Dry powder inhalation, once-daily, single-dose
Salbutamol 400 μgDrug
Pressurized inhalation suspension, once-daily, single-dose
Salbutamol placeboDrug
Pressurized inhalation, once-daily
LAS100977 placeboDrug
Dry powder inhalation, once-daily
| Study group | Role | What they receive |
|---|---|---|
| LAS100977 0.625 μg | Experimental | Single-dose LAS100977 0.625 μg, during double-blind treatment period Receives: Drug: LAS100977 0.625 μg; Drug: Salbutamol placebo |
| LAS100977 1.25 μg | Experimental | Single-dose LAS100977 1.25 μg, during double-blind treatment period Receives: Drug: LAS100977 1.25 μg; Drug: Salbutamol placebo |
| LAS100977 2.5 μg | Experimental | Single-dose LAS100977 2.5 μg, during double-blind treatment period Receives: Drug: LAS100977 2.5 μg; Drug: Salbutamol placebo |
| Salbutamol | Active comparator | Single-dose salbutamol 400 μg, during double-blind treatment period Receives: Drug: Salbutamol 400 μg; Drug: LAS100977 placebo |
| Placebo | Placebo comparator | Placebo to LAS100977, and placebo to salbutamol Receives: Drug: Salbutamol placebo; Drug: LAS100977 placebo |
| LAS100977 0.313 μg | Experimental | Single-dose LAS100977 0.313 μg, during double-blind treatment period Receives: Drug: LAS100977 0.313 μg; Drug: Salbutamol placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
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.
Measured: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Secondary outcomes (15)
Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
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.
Measured: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Peak Forced Expiratory Volume in One Second (FEV1)
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.
Measured: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Time to Peak Forced Expiratory Volume in One Second (FEV1)
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.
Measured: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)
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.
Measured: Baseline and +23 h and +24 h post-dose
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1
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.
Measured: 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
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
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.
Measured: 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
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
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.
Measured: 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
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
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.
Measured: 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
Change From Baseline in Peak Forced Vital Capacity (FVC)
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 and FVC were selected.
Measured: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Peak Forced Vital Capacity (FVC)
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.
Measured: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h
Time to Peak Forced Vital Capacity (FVC)
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.
Measured: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h
Change From Baseline to Trough Forced Vital Capacity (FVC)
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.
Measured: Baseline and +23 h +24 h post-dose
Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC)
FVC 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.
Measured: 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
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
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.
Measured: 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
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study start1 Aug 2011
- Primary completion1 Feb 2012
- Study completion1 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carol Astbury, PhD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425801
- Sponsor's protocol ID
- M/100977/202
- Status last verified
- Apr 2018
- First submitted
- 29 Aug 2011
- Last updated
- 8 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Singh D, Pujol H, Ribera A, Seoane B, Massana E, Astbury C, Ruiz S, de Miquel G. A dose-ranging study of the bronchodilator effects of abediterol (LAS100977), a long-acting beta2-adrenergic agonist, in asthma; a Phase II, randomized study. BMC Pulm Med. 2014 Nov 14;14:176. doi: 10.1186/1471-2466-14-176.
PubMed 25398689
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomised, Single Dose, Double-blind, Double-dummy, 6 Way Complete Cross-over, Placebo Controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of 4 Doses of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Persistent Asthma.
- ClinicalTrials.gov ID
- NCT01425801
- Acronym / sponsor ID
- M/100977/202
- Conditions
- Asthma
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2011 (actual)
- Primary completion
- 1 Feb 2012 (actual)
- Study completion
- 1 Feb 2012 (actual)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Posted 26 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LAS100977 0.625 μg | Experimental | Drug: LAS100977 0.625 μg, Drug: Salbutamol placeboSingle-dose LAS100977 0.625 μg, during double-blind treatment period |
| LAS100977 1.25 μg | Experimental | Drug: LAS100977 1.25 μg, Drug: Salbutamol placeboSingle-dose LAS100977 1.25 μg, during double-blind treatment period |
| LAS100977 2.5 μg | Experimental | Drug: LAS100977 2.5 μg, Drug: Salbutamol placeboSingle-dose LAS100977 2.5 μg, during double-blind treatment period |
| Salbutamol | Active comparator | Drug: Salbutamol 400 μg, Drug: LAS100977 placeboSingle-dose salbutamol 400 μg, during double-blind treatment period |
| Placebo | Placebo comparator | Drug: Salbutamol placebo, Drug: LAS100977 placeboPlacebo to LAS100977, and placebo to salbutamol |
| LAS100977 0.313 μg | Experimental | Drug: LAS100977 0.313 μg, Drug: Salbutamol placeboSingle-dose LAS100977 0.313 μg, during double-blind treatment period |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male and female patients aged 18-70 years (both included).
- Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for at least 6 months prior to screening.
- Screening FEV1 value of 60% < FEV1 ≤ 85% of the predicted normal value.
- FEV1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline value after inhalation of 400µg (four inhalations) of salbutamol.
- Pre-dose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation.
Key exclusion criteria (9 listed)
- Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years.
- Patients diagnosed with COPD.
- Recent Respiratory tract infections within 6 weeks before Screening Visit.
- Intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit.
- Clinically significant respiratory conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAS100977 0.313 μgDry powder inhalation, once-daily, single-dose | Drug | LAS100977 0.313 μg |
| LAS100977 0.625 μgDry powder inhalation, once-daily, single-dose | Drug | LAS100977 0.625 μg |
| LAS100977 1.25 μgDry powder inhalation, once-daily, single-dose | Drug | LAS100977 1.25 μg |
| LAS100977 2.5 μgDry powder inhalation, once-daily, single-dose | Drug | LAS100977 2.5 μg |
| Salbutamol 400 μgPressurized inhalation suspension, once-daily, single-dose | Drug | Salbutamol |
| Salbutamol placeboPressurized inhalation, once-daily | Drug | LAS100977 0.313 μg, LAS100977 0.625 μg, LAS100977 1.25 μg, LAS100977 2.5 μg, Placebo |
| LAS100977 placeboDry powder inhalation, once-daily | Drug | Placebo, Salbutamol |
Primary outcome
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Time frame: 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.
15 secondary outcomes
Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Peak Forced Expiratory Volume in One Second (FEV1)
Time frame: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Time to Peak Forced Expiratory Volume in One Second (FEV1)
Time frame: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline and +23 h and +24 h post-dose
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1
Time frame: 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
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
Time frame: 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
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
Time frame: 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
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
Time frame: 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
Change From Baseline in Peak Forced Vital Capacity (FVC)
Time frame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Peak Forced Vital Capacity (FVC)
Time frame: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h
Time to Peak Forced Vital Capacity (FVC)
Time frame: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h
Change From Baseline to Trough Forced Vital Capacity (FVC)
Time frame: Baseline and +23 h +24 h post-dose
Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC)
Time frame: 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
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
Time frame: 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
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25398689Singh D, Pujol H, Ribera A, Seoane B, Massana E, Astbury C, Ruiz S, de Miquel G. A dose-ranging study of the bronchodilator effects of abediterol (LAS100977), a long-acting beta2-adrenergic agonist, in asthma; a Phase II, randomized study. BMC Pulm Med. 2014 Nov 14;14:176. doi: 10.1186/1471-2466-14-176.
- Synopsis-M-100977-202Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Astbury, PhD study director
AstraZeneca
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LAS100977 0.313 μg, LAS100977 0.625 μg and LAS100977 1.25 μg in people with Asthma, run by AstraZeneca at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) (time frame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01425801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.