Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT01425814
Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population
A Phase 2 study testing LAS100977 and Reference in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 8 sites in Germany.
Trial summary
The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single doses of inhaled LAS100977 in COPD patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- LAS100977 and Reference
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 8 sitesGermany
- Study dates
- Aug 2011to Mar 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and non-pregnant, non-lactating females aged 40 or older.
- Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction.
- Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value
- Post-salbutamol FEV1/FVC < 70% at screening visit.
- Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation.
- Current, or ex-cigarette smokers (former) with a smoking history of at least 10 pack-years.
- Patients whose COPD symptoms at the time of randomisation are stable compared to the Screening visit, according to the investigator's medical judgment.
Who cannot join
- History or current diagnosis of asthma.
- A respiratory tract infection or COPD exacerbation in the six weeks prior to the screening visit.
- Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
- Clinically significant respiratory conditions other than COPD condition.
- Clinically significant cardiovascular conditions.
- 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
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Almirall Investigational Sites#5
Berlin, 14050
Almirall Investigational Sites#2
Berlin, 14057
Almirall Investigational Sites#6
Frankfurt, 60596
Almirall Investigational Sites#3
Großhansdorf, 22927
Almirall Investigational Sites#7
Hamburg, 20354
Almirall Investigational Sites#8
Lübeck, 23552
Almirall Investigational Sites#1
Mainz, 55131
Almirall Investigational Sites#4
Wiesbaden, 65187
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 Strengths of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single doses of inhaled LAS100977 in COPD patients.
- Being tested
- LAS100977, Reference, Placebo
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAS100977Drug
Dry powder inhalation,Once daily, single dose
LAS100977Drug
Dry powder inhalation,Once daily, single dose
LAS100977Drug
Dry powder inhalation,Once daily, single dose
LAS100977Drug
Dry powder inhalation,Once daily, single dose
ReferenceDrug
Dry powder inhalation (capsule),single dose
PlaceboDrug
Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose
| Study group | Role | What they receive |
|---|---|---|
| Arm #2 | Experimental | Single dose, double blind treatment period Receives: Drug: LAS100977 |
| Arm #3 | Experimental | Single dose, double blind treatment period Receives: Drug: LAS100977 |
| Arm #4 | Experimental | Single dose, double blind treatment period Receives: Drug: LAS100977 |
| Arm #5 | Active comparator | Single dose, double blind treatment period Receives: Drug: Reference |
| Arm #6 | Placebo comparator | Single dose, double blind treatment period Receives: Drug: Placebo |
| Arm #1 | Experimental | Single dose, double blind treatment period Receives: Drug: LAS100977 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 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: Day 2
Secondary outcomes (13)
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve
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: Day 1
Change From Baseline in 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) 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: Up to Day 2
Absolute Forced Expiratory Volume in One Second (FEV1) Values
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: Up to Day 2
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) 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: Day 1
Time to Peak Forced Expiratory Volume in One Second (FEV1)
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: Day 1
Change From Baseline in 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: Day 2
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve
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: Day 1
Change From Baseline in 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) 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: Up to Day 2
Absolute Forced Vital Capacity (FVC) Values
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: Up to Day 2
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) 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: Day 1
Time to Peak Forced Vital Capacity (FVC)
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: Day 1
Change From Baseline in Inspiratory Capacity (IC)
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
Measured: Up to Day 2
Absolute Inspiratory Capacity (IC) Values
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
Measured: Up to Day 2
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 startAug 2011
- Primary completionMar 2012
- Study completionMar 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 Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- 87 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
- NCT01425814
- Sponsor's protocol ID
- M/100977/25
- Other IDs
- LBC25
- Status last verified
- Feb 2017
- First submitted
- 29 Aug 2011
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Beier J, Pujol H, Seoane B, Jimenez E, Astbury C, Massana E, Ruiz S, de Miquel G. Abediterol, a novel long-acting beta2-agonist: bronchodilation, safety, tolerability and pharmacokinetic results from a single-dose, dose-ranging, active-comparator study in patients with COPD. BMC Pulm Med. 2016 Jul 20;16(1):102. doi: 10.1186/s12890-016-0266-5.
PubMed 27439370
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. 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 Strengths of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01425814
- Acronym / sponsor ID
- M/100977/25
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Posted 10 Apr 2017
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 (bronchodilation) of single doses of inhaled LAS100977 in COPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm #2 | Experimental | Drug: LAS100977Single dose, double blind treatment period |
| Arm #3 | Experimental | Drug: LAS100977Single dose, double blind treatment period |
| Arm #4 | Experimental | Drug: LAS100977Single dose, double blind treatment period |
| Arm #5 | Active comparator | Drug: ReferenceSingle dose, double blind treatment period |
| Arm #6 | Placebo comparator | Drug: PlaceboSingle dose, double blind treatment period |
| Arm #1 | Experimental | Drug: LAS100977Single dose, double blind treatment period |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and non-pregnant, non-lactating females aged 40 or older.
- Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction.
- Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value
- Post-salbutamol FEV1/FVC < 70% at screening visit.
- Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation.
Key exclusion criteria (8 listed)
- History or current diagnosis of asthma.
- A respiratory tract infection or COPD exacerbation in the six weeks prior to the screening visit.
- Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
- Clinically significant respiratory conditions other than COPD condition.
- Clinically significant cardiovascular 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 |
|---|---|---|
| LAS100977Dry powder inhalation,Once daily, single dose | Drug | Arm #1 |
| LAS100977Dry powder inhalation,Once daily, single dose | Drug | Arm #2 |
| LAS100977Dry powder inhalation,Once daily, single dose | Drug | Arm #3 |
| LAS100977Dry powder inhalation,Once daily, single dose | Drug | Arm #4 |
| ReferenceDry powder inhalation (capsule),single dose | Drug | Arm #5 |
| PlaceboDry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose | Drug | Arm #6 |
Primary outcome
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)
Time frame: 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
13 secondary outcomes
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve
Time frame: Day 1
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Time frame: Up to Day 2
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Time frame: Up to Day 2
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Time frame: Day 1
Time to Peak Forced Expiratory Volume in One Second (FEV1)
Time frame: Day 1
Change From Baseline in Trough Forced Vital Capacity (FVC)
Time frame: Day 2
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve
Time frame: Day 1
Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Up to Day 2
Absolute Forced Vital Capacity (FVC) Values
Time frame: Up to Day 2
Change From Baseline in Peak Forced Vital Capacity (FVC)
Time frame: Day 1
Time to Peak Forced Vital Capacity (FVC)
Time frame: Day 1
Change From Baseline in Inspiratory Capacity (IC)
Time frame: Up to Day 2
Absolute Inspiratory Capacity (IC) Values
Time frame: Up to Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27439370Beier J, Pujol H, Seoane B, Jimenez E, Astbury C, Massana E, Ruiz S, de Miquel G. Abediterol, a novel long-acting beta2-agonist: bronchodilation, safety, tolerability and pharmacokinetic results from a single-dose, dose-ranging, active-comparator study in patients with COPD. BMC Pulm Med. 2016 Jul 20;16(1):102. doi: 10.1186/s12890-016-0266-5.
- CSR SynopsisLink 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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LAS100977 and Reference in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 8 sites in Germany.
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 7 inclusion and 8 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 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. 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 10 Apr 2017). 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 Trough Forced Expiratory Volume in One Second (FEV1) (time frame: Day 2). 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 NCT01425814, 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 10 Apr 2017.