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LAS100977

Phase 2

Chronic Obstructive Pulmonary Disease (COPD) | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Apr 10, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment87

FDA Designations

No designations recorded

Clinical trial landscape

LAS100977 · 1 trial · 1 indication

Phase 2 1
NCT01425814Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) PopulationChronic Obstructive Pulmonary Disease (COPD)
COMPLETED87 Analytics
PHASE2COMPLETED
Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)
Day 2

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

Secondary Endpoints

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve
Day 1
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Up to Day 2
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Up to Day 2
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm #2EXPERIMENTALSingle dose, double blind treatment period
Arm #3EXPERIMENTALSingle dose, double blind treatment period
Arm #4EXPERIMENTALSingle dose, double blind treatment period
Arm #5ACTIVE_COMPARATORSingle dose, double blind treatment period
Arm #6PLACEBO_COMPARATORSingle dose, double blind treatment period
Arm #1EXPERIMENTALSingle dose, double blind treatment period

Interventions

NameTypeDescription
LAS100977DRUGDry powder inhalation,Once daily, single dose
ReferenceDRUGDry powder inhalation (capsule),single dose
PlaceboDRUGDry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Males and non-pregnant, non-lactating females aged 40 or older. 2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction. 3. Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less ...

Countries:Germany
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Frequently asked questions about LAS100977

What is LAS100977 used for?

LAS100977 is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who is developing LAS100977?

LAS100977 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is in Phase 2 clinical trials for Chronic Obstructive Pulmonary Disease (COPD).

What phase is LAS100977 in?

LAS100977 is in Phase 2 clinical development. It is an investigational drug for Chronic Obstructive Pulmonary Disease (COPD) and has not yet been approved for commercial use.

What clinical trials is LAS100977 in?

LAS100977 has one completed Phase 2 clinical trial, identified as NCT01425814. This was a single-dose study assessing the efficacy and safety of four doses of LAS100977 in patients with Chronic Obstructive Pulmonary Disease (COPD). The trial enrolled 87 participants in Germany.

Is LAS100977 the same as any other drug?

LAS100977 is the primary name for this investigational drug. No alternative names have been reported for this compound in its clinical development program.