Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT02059434

Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD

A Phase 1 study testing LAS190792 Dose 1, LAS190792 Dose 2 and LAS190792 Dose 3 in people with Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by AstraZeneca at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the safety and tolerability of single doses of LAS190792 administered by inhalation to patients with mild persistent asthma and moderate to severe chronic obstructive pulmonary disease (COPD) and also to assess the ability of LAS190792 to produce bronchodilation (opening of the… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD), Asthma
What is being tested?: LAS190792 Dose 1, LAS190792 Dose 2 and LAS190792 Dose 3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 2 sitesUnited Kingdom
Study dates: 1 Sep 2013to 6 Oct 2014
Phase: Phase 1
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 subjects aged 18 to 70 years
Body mass index (BMI) 18.5 to 30 kg/m2 at screening
Clinical diagnosis of mild persistent asthma (according to GINA guidelines) for at least 6 months prior to screening
Ability to change current asthma therapy, to discontinue previous prescribed medications after signature of informed consent as per required washout periods
Screening FEV1 value of ≥70% of the predicted normal value after a washout of at least 5 h for short-acting beta2-agonists and 72 h for long-acting beta2-agonists
FEV1 reversibility of ≥12% and an absolute increase of at least 200 mL over the baseline value within 30 min after inhalation of 400 µg of salbutamol

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Subjects using intermittent salbutamol and / or subjects on a stable dose or regimen of low dose ICS (as defined by the GINA guidelines) at least 4 weeks prior to screening
Predose FEV1 value of first treatment period within the range of ±20% of the FEV1 measured at screening prior to salbutamol inhalation
Subjects who are otherwise healthy as determined by medical history, physical examination, 12-lead ECG findings
Normal blood pressure (defined as SBP between 100 and 140 mmHg, and DBP between 50 and 90 mmHg) at screening, measured after resting in supine position for 5 minutes.
Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator
Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis B core (HBc) antibody (IgM), hepatitis C antibody and human immunodeficiency virus (HIV) I and II antibodies at screening
Subjects who are able and willing to provide written informed consent
Subjects able to perform repeatable pulmonary function testing for FEV1 according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005 criteria at screening
Adult male and non-childbearing potential women subjects aged ≥40 years with a clinical diagnosis of stable moderate to severe COPD according to GOLD guidelines at screening
Females must be of non-childbearing potential, confirmed at screening
Post-salbutamol FEV1 <80% and ≥30% of the predicted normal value and post-salbutamol FEV1 / forced vital capacity (FVC) <70%
Ability to change current COPD therapy, to discontinue previous prescribed medications after signature of informed consent
No evidence of clinically significant respiratory and / or cardiovascular conditions or laboratory abnormalities
No other relevant pulmonary disease or history of thoracic surgery
No contraindication to the use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction, narrow-angle glaucoma, or beta2-agonists usage
Subjects who are negative for HBsAg, HBc IgM, hepatitis C antibody and HIV I and II antibodies at screening
Subjects who are able and willing to provide written informed consent
Subjects able to perform repeatable pulmonary function testing for FEV1 according to the ATS / ERS 2005 criteria at screening

Who cannot join

Subjects who do not conform to the above inclusion criteria
Current smokers, subjects with a smoking history during the last 12 months or subjects with a smoking history of more than 10 pack-years
Other relevant pulmonary disease or history of thoracic surgery
Subjects with a BMI ≥40 kg/m2 (only applicable for Part 2)
Subjects with any clinically relevant history or presence of abnormality from the medical history and/or physical examination (only applicable for Part 1)
Current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality that could put the subject at risk or could confound the results of the study (only applicable for Part 2)

Show all 33Show fewer

Subjects with a surgical history clinically relevant for the purpose of the study
History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin
Subjects with serious adverse reaction or serious hypersensitivity to Spiriva (for Part 2 only), indacaterol (for Part 2 only), or the formulation excipients (eg, lactose) or other drugs in the same pharmacologic class (for Part 1 and Part 2)
Current diagnosis of COPD (for Part 1 only) or history of / or current diagnosis for asthma (for Part 2 only)
Recent history of asthma / COPD exacerbation requiring hospitalisation or need for increased maintenance treatments for asthma / COPD within 6 weeks prior to screening or randomisation
Use of daily oxygen therapy >10 h per day (for Part 2 only)
Use of systemic steroids for respiratory reasons within 3 months prior to screening
Lower respiratory tract infection within 6 weeks prior to screening or randomisation
Upper respiratory tract infection requiring antibiotics within 4 weeks prior to screening or randomisation
Current history of tuberculosis, bronchiectasis or other non-specific pulmonary disease
QTcF interval >430 ms at screening or prior to randomisation, or history of long QT syndrome (for Part 1 only)
QTcF interval, >450 ms for males and >470 ms for females at screening or prior to randomisation, or history of long QT syndrome (for Part 2 only)
Subjects with a history of excessive use or abuse of alcohol or with a history of drug abuse within the past 2 years
Subjects who are positive for drugs of abuse and alcohol tests at screening and prior to randomisation
Donation or loss >400 ml of blood and plasma within the previous 3 months prior to screening
Subjects consuming more than 14 (female subjects) or 21 (male subjects) units of alcohol a week
Subjects with a significant infection or known inflammatory process at screening or prior to randomisation
Subjects with acute gastrointestinal symptoms at the time of screening or prior to randomisation
Subjects with an acute infection such as influenza at the time of screening or prior to randomisation
Male subjects who do not agree to follow instructions to avoid pregnancies
Subjects who are not able to adhere to the restrictions on prior and concomitant medications
Subjects who intend to use any concomitant medication not permitted by the protocol or who have not undergone the required washout period for a particular prohibited medication
Subjects who have used any investigational drug within 3 months prior to screening or within the equivalent time of 6 half-lives of receiving the last administration, whichever is longer
Subjects who have received the last dose of investigational product more than 3 months ago but who are on an extended follow-up
Subjects who are vegans or who have medical dietary restrictions
Subjects unable to communicate reliably with the Investigator
Subjects who are unlikely to co-operate with the requirements of the study

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Quintiles Drug Research Unit at Guy's Hospital
London, SE1 1YR
Medicines Evaluation Unit Ltd (MEU)
Manchester, M23 9QZ

Other trials in United Kingdom

About this study

Official title: A 2-Part, Randomised, Placebo-Controlled, Safety, Tolerability, Pharmacokinetic And Pharmacodynamic Study Of LAS190792 Delivered By Inhalation In Asthmatic And Chronic Obstructive Pulmonary Disease (COPD) Subjects

Read the detailed description

This study is an integrated Phase I protocol divided into 2 parts.

Part one: a single ascending dose study (6 LAS190792 dose levels) in 16 male subjects with mild asthma. LAS190792 will be administered (by the Genuair® inhaler) under supervision at the study centre, according to the randomisation scheme. One dose level will be administered per week with 2 to 3 weeks between each dose level for the safety and pharmacokinetic data review.

Part two: A 5-way , crossover, single dose study (of LAS190792 [two doses], indacaterol, tiotropium and placebo) in 40 male and non-childbearing potential women subjects with moderate to severe COPD. Each treatment period will be separated by a washout period of at least 7 to 14 days. The aim is to ensure at least 30 subjects complete Part 2 of the study. The primary comparison for bronchodilation will be between LAS190792 doses and placebo. Other treatment comparisons (indacaterol or tiotropium vs placebo and LAS190792 vs indacaterol or tiotropium) will be considered additional.

Conditions: Chronic Obstructive Pulmonary Disease (COPD), Asthma
Being tested: LAS190792 Dose 1, LAS190792 Dose 2, LAS190792 Dose 3, LAS190792 Dose 4, LAS190792 Dose 5
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LAS190792 Dose 1Drug
LAS190792 Dose 2Drug
LAS190792 Dose 3Drug
LAS190792 Dose 4Drug
LAS190792 Dose 5Drug
LAS190792 Dose 6Drug
LAS190792 Dose 1 (Part 2)Drug
LAS190792 Dose 2 (Part 2)Drug
Tiotropium 18 μgDrug
Also called Spiriva
Indacaterol 150 μgDrug
Also called Onbrez
PlaceboDrug

Study groups in NCT02059434
Study group	Role	What they receive
LAS190792 Dose 1 (Part 1)	Experimental	Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) Receives: Drug: LAS190792 Dose 1
LAS190792 Dose 2 (Part 1)	Experimental	Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) Receives: Drug: LAS190792 Dose 2
LAS190792 Dose 3 (Part 1)	Experimental	Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) Receives: Drug: LAS190792 Dose 3
LAS190792 Dose 4 (Part 1)	Experimental	Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) Receives: Drug: LAS190792 Dose 4
LAS190792 Dose 5 (Part 1)	Experimental	Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) Receives: Drug: LAS190792 Dose 5
LAS190792 Dose 6 (Part 1)	Experimental	Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) Receives: Drug: LAS190792 Dose 6
Placebo (Part 1)	Placebo comparator	Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) Receives: Drug: Placebo
LAS190792 Dose 1 (Part 2)	Experimental	Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) Receives: Drug: LAS190792 Dose 1 (Part 2)
LAS190792 Dose 2 (Part 2)	Experimental	Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) Receives: Drug: LAS190792 Dose 2 (Part 2)
Tiotropium 18 μg	Active comparator	Single dose, oral inhalation by HandiHaler® single-dose DPI Receives: Drug: Tiotropium 18 μg
Indacaterol 150 μg	Active comparator	Single dose, oral inhalation by Breezhaler® single-dose DPI Receives: Drug: Indacaterol 150 μg
Placebo (Part 2)	Placebo comparator	Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjects With ≥1 Treatment-emergent Adverse Event
Adverse events (AEs) are any unfavorable and unintended medical occurrence during the subject's participation in the study (including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, an ECG abnormality, a 12-lead 24-hour ECG-Holter abnormality, a blood pressure abnormal value, paradoxal bronchospasm or an abnormal finding in the physical examination) and will be coded using the current Medical Dictionary for Regulatory Activities (MedDRA).
Measured: 30 Days
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second)
Trough is defined as the mean of the FEV1 values obtained at 23 hours and at 24 hours after morning investigational product administration.
Measured: Day 2

Secondary outcomes (3)

Maximum Observed Plasma Concentration (Cmax)
Measured: Up to 36 hours after investigational product administration
Time to Maximum Observed Plasma Concentration (Tmax)
Measured: Up to 36 hours after investigational product administration
Area Under the Concentration-time Curve From Zero to the Time of the Last Measurable Concentration
Measured: Up to 36 hours after investigational product administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20136 Oct 2014

First posted11 Feb 2014 (estimated)
Study start1 Sep 2013
Primary completion6 Oct 2014
Study completion6 Oct 2014

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.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02059434
Sponsor's protocol ID: M-190792-01
Other IDs: 2013-001758-93
Status last verified: Mar 2019
First submitted: 7 Feb 2014
Last updated: 21 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 2-Part, Randomised, Placebo-Controlled, Safety, Tolerability, Pharmacokinetic And Pharmacodynamic Study Of LAS190792 Delivered By Inhalation In Asthmatic And Chronic Obstructive Pulmonary Disease (COPD) Subjects
ClinicalTrials.gov ID: NCT02059434
Acronym / sponsor ID: M-190792-01
Conditions: Chronic Obstructive Pulmonary Disease (COPD), Asthma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 1 Sep 2013 (actual)
Primary completion: 6 Oct 2014 (actual)
Study completion: 6 Oct 2014 (actual)
First posted: 11 Feb 2014 (estimated)
Results: Posted 21 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study is an integrated Phase I protocol divided into 2 parts.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 12

Arm	Type	Receives
LAS190792 Dose 1 (Part 1)	Experimental	Drug: LAS190792 Dose 1Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 2 (Part 1)	Experimental	Drug: LAS190792 Dose 2Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 3 (Part 1)	Experimental	Drug: LAS190792 Dose 3Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 4 (Part 1)	Experimental	Drug: LAS190792 Dose 4Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 5 (Part 1)	Experimental	Drug: LAS190792 Dose 5Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 6 (Part 1)	Experimental	Drug: LAS190792 Dose 6Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
Placebo (Part 1)	Placebo comparator	Drug: PlaceboSingle dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 1 (Part 2)	Experimental	Drug: LAS190792 Dose 1 (Part 2)Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
LAS190792 Dose 2 (Part 2)	Experimental	Drug: LAS190792 Dose 2 (Part 2)Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)
Tiotropium 18 μg	Active comparator	Drug: Tiotropium 18 μgSingle dose, oral inhalation by HandiHaler® single-dose DPI
Indacaterol 150 μg	Active comparator	Drug: Indacaterol 150 μgSingle dose, oral inhalation by Breezhaler® single-dose DPI
Placebo (Part 2)	Placebo comparator	Drug: PlaceboSingle dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

Adult male subjects aged 18 to 70 years
Body mass index (BMI) 18.5 to 30 kg/m2 at screening
Clinical diagnosis of mild persistent asthma (according to GINA guidelines) for at least 6 months prior to screening
Ability to change current asthma therapy, to discontinue previous prescribed medications after signature of informed consent as per required washout periods
Screening FEV1 value of ≥70% of the predicted normal value after a washout of at least 5 h for short-acting beta2-agonists and 72 h for long-acting beta2-agonists

Key exclusion criteria (33 listed)

Subjects who do not conform to the above inclusion criteria
Current smokers, subjects with a smoking history during the last 12 months or subjects with a smoking history of more than 10 pack-years
Other relevant pulmonary disease or history of thoracic surgery
Subjects with a BMI ≥40 kg/m2 (only applicable for Part 2)
Subjects with any clinically relevant history or presence of abnormality from the medical history and/or physical examination (only applicable for Part 1)

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
LAS190792 Dose 1	Drug	LAS190792 Dose 1 (Part 1)
LAS190792 Dose 2	Drug	LAS190792 Dose 2 (Part 1)
LAS190792 Dose 3	Drug	LAS190792 Dose 3 (Part 1)
LAS190792 Dose 4	Drug	LAS190792 Dose 4 (Part 1)
LAS190792 Dose 5	Drug	LAS190792 Dose 5 (Part 1)
LAS190792 Dose 6	Drug	LAS190792 Dose 6 (Part 1)
LAS190792 Dose 1 (Part 2)	Drug	LAS190792 Dose 1 (Part 2)
LAS190792 Dose 2 (Part 2)	Drug	LAS190792 Dose 2 (Part 2)
Tiotropium 18 μgAlso: Spiriva	Drug	Tiotropium 18 μg
Indacaterol 150 μgAlso: Onbrez	Drug	Indacaterol 150 μg
Placebo	Drug	Placebo (Part 1), Placebo (Part 2)

Primary outcome

Subjects With ≥1 Treatment-emergent Adverse Event
Time frame: 30 Days
Adverse events (AEs) are any unfavorable and unintended medical occurrence during the subject's participation in the study (including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, an ECG abnormality, a 12-lead 24-hour ECG-Holter abnormality, a blood pressure abnormal value, paradoxal bronchospasm or an abnormal finding in the physical examination) and will be coded using the current Medical Dictionary for Regulatory Activities (MedDRA).
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second)
Time frame: Day 2
Trough is defined as the mean of the FEV1 values obtained at 23 hours and at 24 hours after morning investigational product administration.

3 secondary outcomes

Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 36 hours after investigational product administration
Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to 36 hours after investigational product administration
Area Under the Concentration-time Curve From Zero to the Time of the Last Measurable Concentration
Time frame: Up to 36 hours after investigational product administration

Results and safety

Results posted to the registry on 21 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1 - Cohort 1 LAS190792 5 μg, 50 μg, 200 μg	2	2
Part 1 - Cohort 1 Placebo, Then LAS190792 50 μg, 200 μg	2	2
Part 1 - Cohort 1 LAS190792 5 μg, Placebo, LAS190792 200 μg	2	2
Part 1 - Cohort 1 LAS190792 5 μg, 50 μg, Then Placebo	2	2
Part 1 - Cohort 2 LAS190792 20 μg, 100 μg, 400 μg	2	2
Part 1 - Cohort 2 Placebo, Then LAS190792 100 μg, 400 μg	2	2
Part 1 - Cohort 2 LAS190792 20 μg, Placebo, LAS190792 400 μg	2	2
Part 1 - Cohort 2 LAS190792 20 μg, 100 μg, Then Placebo	3	3
Overall Population - Part 2	0	0

Primary outcome: Subjects With ≥1 Treatment-emergent Adverse Event

Time frame: 30 Days. Number. Unit: Participants

Measure	LAS190792 5 µg (Part 1) n = 6	LAS190792 20 µg (Part 1) n = 6	LAS190792 50 µg (Part 1) n = 6	LAS190792 100 µg (Part 1) n = 6	LAS190792 200 µg (Part 1) n = 6	LAS190792 400 µg (Part 1) n = 6	Placebo (Part 1) n = 12	LAS190792 100 µg (Part 2) n = 36	LAS190792 400 µg (Part 2) n = 35	Tiotropium 18 μg n = 37	Indacaterol 150 μg n = 37	Placebo (Part 2) n = 37
Value	2	3	2	2	2	4	3	12	12	14	21	15

Population analysed: Safety Population: defined as all randomized subjects who received at least one dose of the investigational product

Primary outcome: Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second)

Time frame: Day 2. Mean (Standard Deviation). Unit: Liters

Measure	LAS190792 5 µg (Part 1) n = 6	LAS190792 20 µg (Part 1) n = 6	LAS190792 50 µg (Part 1) n = 6	LAS190792 100 µg (Part 1) n = 6	LAS190792 200 µg (Part 1) n = 6	LAS190792 400 µg (Part 1) n = 6	Placebo (Part 1) n = 12	LAS190792 100 µg (Part 2) n = 36	LAS190792 400 µg (Part 2) n = 35	Tiotropium 18 μg n = 37	Indacaterol 150 μg n = 37	Placebo (Part 2) n = 37
Value	-0.013 (0.333)	0.161 (0.131)	0.523 (0.448)	0.536 (0.170)	0.371 (0.333)	0.599 (0.316)	0.029 (0.144)	1.369 (0.505)	1.360 (0.472)	1.379 (0.502)	1.361 (0.481)	1.338 (0.506)

LAS190792 100 µg (Part 2) vs Placebo (Part 2): Least squares mean difference: 0.104 (95% CI 0.060 to 0.149), p <0.0001, ANCOVA
LAS190792 400 µg (Part 2) vs Placebo (Part 2): Least squares mean difference: 0.178 (95% CI 0.133 to 0.223), p <0.0001, ANCOVA

Population analysed: Per Protocol Population: defined as all randomized subjects who satisfied the main inclusion / exclusion criteria, received investigational product, completed at least one treatment period, and did not present major violations to the protocol.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LAS190792 5 µg (Part 1)	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
LAS190792 20 µg (Part 1)	0 of 6 (0%)	3 of 6 (50%)	Not reported
LAS190792 50 µg (Part 1)	1 of 6 (16.7%)	1 of 6 (16.7%)	Not reported
LAS190792 100 µg (Part 1)	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
LAS190792 200 µg (Part 1)	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
LAS190792 400 µg (Part 1)	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Placebo (Part 1)	0 of 12 (0%)	3 of 12 (25%)	Not reported
LAS190792 100 µg (Part 2)	0 of 36 (0%)	4 of 36 (11.1%)	Not reported
LAS190792 400 µg (Part 2)	0 of 35 (0%)	9 of 35 (25.7%)	Not reported
Tiotropium 18 μg	0 of 37 (0%)	6 of 37 (16.2%)	Not reported
Indacaterol 150 μg	0 of 37 (0%)	15 of 37 (40.5%)	Not reported
Placebo (Part 2)	0 of 37 (0%)	11 of 37 (29.7%)	Not reported

Limitations and caveats (from the sponsor): In Part 1, many plasma concentrations at 50-100µg dose levels were BLOQ; thus only limited PK data were obtained for AUC(0-t), with plasma concentrations generally detected up to 1h post-administration; and at 200-400µg, up to 6 or 12h, respectively

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 24 inclusion and 33 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 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 21 Jun 2019). 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?

Subjects With ≥1 Treatment-emergent Adverse Event (time frame: 30 Days). The study lists 2 primary outcomes in all. 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 NCT02059434.

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 21 Jun 2019.