Healthy VolunteersPhase 4NCT01877642

ADASUVE-Lorazepam Drug-Drug Interaction

A Phase 4 study testing Lorazepam 1 mg IM and Inhaled loxapine 10 mg in people with Healthy Volunteers, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.

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

This study will compare the safety and effects over time for giving both ADASUVE and lorazepam (intramuscular) compared to that of each agent given alone. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Lorazepam 1 mg IM and Inhaled loxapine 10 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Jul 2013
Phase: Phase 4
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male and female subjects between the ages of 18 to 50 years, inclusive.
Body mass index (BMI) ≥18 and ≤32.
Subjects who are willing and able to comply with the study schedule and requirements, and stay at the CRU for 9 days.
Subjects who speak, read, and understand English and are willing and able to provide written informed consent on an IRB approved form prior to the initiation of any study procedures.
Subjects who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
Female participants (if of child-bearing potential and sexually active) who agree to use a medically acceptable and effective birth control method throughout the study and for 30 days following the end of the study
Male participants (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method from the first dose and for 90 days following last dose of study drug. Male participants must refrain from donating sperm for the same period.

Who cannot join

Subject history, which includes: any cardiovascular disease or disorder; asthma, chronic obstructive lung disease, or any use of an inhaler prescribed for wheezing or bronchospasm must be excluded; sleep apnea; acute narrow-angle glaucoma; any neurological, gastrointestinal, hepatic, renal, hematologic, endocrine and/or metabolic disease or disorder; psychiatric illness or mental disorder except for short term situational anxiety or depression of < 2 years duration; any substance abuse or addiction within the last 2 years; pregnancy within the past 6 months.
Subjects who have taken prescription or nonprescription medication within 7 days of Visit 2.
Subjects who have had an acute illness within the last 7 days of Visit 2.
Subjects who have a history of HIV positivity.
Subjects who test positive for alcohol or have a positive urine drug screen.
Subjects who have a history of allergy or intolerance to loxapine or amoxapine.

Show all 12Show fewer

Subjects who have a history of allergy or intolerance to lorazepam or any other benzodiazepine.
Subjects who have a history of allergy or intolerance to polyethylene glycol, propylene glycol, or benzyl alcohol
Female subjects who have a positive pregnancy test at screening or at admission to Visit 2, or are breastfeeding.
Subjects who have received an investigational drug within 30 days prior to the Screening Visit.
Subjects who have any other disease(s), by history, physical examination, or laboratory abnormalities that, in the investigator's opinion, presents undue risk to the subject or may confound the interpretation of study results.
Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving lorazepam or ADASUVE.

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance-Evansville
Evansville, Indiana, 47710

Other trials in United States

About this study

Official title: ADASUVE®-Lorazepam Drug-Drug Interaction Study

This study will compare the safety and effects over time for giving both ADASUVE and lorazepam (intramuscular) compared to that of each agent given alone.

Read the detailed description

The objective of this study is to compare the safety and pharmacodynamic profiles of concomitant administration of a single dose of ADASUVE and lorazepam (IM) compared to that of each agent administered alone. Respiratory pharmacodynamics will be monitored through recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures will include effects on blood pressure, heart rate, sedation and psychomotor measures of attention, information processing speed, reaction time, and coordination.

Initially, 4 subjects will receive lorazepam 1 mg IM + ADASUVE 10 mg open label to validate the dose regimen. After the safety data are reviewed and the dose regimen confirmed, 18 non-obese, healthy male or female volunteers between the ages of 18 and 50 will be enrolled in this double-blinded, double-dummy, randomized, 3-period cross-over drug interaction study.

Conditions: Healthy Volunteers
Being tested: Lorazepam 1 mg IM, Inhaled loxapine 10 mg, Inhaled Placebo, Placebo IM
Keywords: ADASUVE, inhaled loxapine, drug drug interaction, lorazepam, acute treatment of agitation

What participants receive

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

Lorazepam 1 mg IMDrug
Also called Ativan 1 mg IM
Lorazepam 1 mg intramuscular
Inhaled loxapine 10 mgDrug
Also called ADASUVE 10 mg
Inhaled Staccato loxapine 10 mg
Inhaled PlaceboDrug
Also called Staccato Placebo
Inhaler with no drug in it to mimic the ADASUVE inhaler
Placebo IMDrug
Also called Saline
intramuscular placebo to mimic lorazepam 1 mg IM

Study groups in NCT01877642
Study group	Role	What they receive
Open Label (lorazepam 1 mg + Inhaled loxapine 10 mg)	Other	Inhaled Staccato loxapine 10 mg + IM lorazepam 1 mg to confirm tolerability of combined treatment Receives: Drug: Lorazepam 1 mg IM; Drug: Inhaled loxapine 10 mg
Treatment Sequence ABC	Other	Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg Receives: Drug: Lorazepam 1 mg IM; Drug: Inhaled loxapine 10 mg; Drug: Inhaled Placebo; Drug: Placebo IM
Treatment Sequence ACB	Other	Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg Receives: Drug: Lorazepam 1 mg IM; Drug: Inhaled loxapine 10 mg; Drug: Inhaled Placebo; Drug: Placebo IM
Treatment Sequence BCA	Other	Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg Receives: Drug: Lorazepam 1 mg IM; Drug: Inhaled loxapine 10 mg; Drug: Inhaled Placebo; Drug: Placebo IM
Treatment Sequence BAC	Other	Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg Receives: Drug: Lorazepam 1 mg IM; Drug: Inhaled loxapine 10 mg; Drug: Inhaled Placebo; Drug: Placebo IM
Treatment Sequence CAB	Other	Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg Receives: Drug: Lorazepam 1 mg IM; Drug: Inhaled loxapine 10 mg; Drug: Inhaled Placebo; Drug: Placebo IM
Treatment Sequence CBA	Other	Treatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg Receives: Drug: Lorazepam 1 mg IM; Drug: Inhaled loxapine 10 mg; Drug: Inhaled Placebo; Drug: Placebo IM

What is being measured

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

Maximum Level of Sedation for Lorazepam 1 mg IM + ADASUVE 10 mg
Determine the maximum level of sedation for Lorazepam 1 mg IM + ADASUVE 10 mg based on the 100 mm Visual Analog Scale (VAS) ranging from (0=sleepy to 100=wide awake)
Measured: 24 hours
Relative Pharmacodynamic Effect on Respiration Rate for Combined vs Individual (Lorazepam, Loxapine)
LS Mean ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for respiration rate following administration of Lorazepam+Loxapine compared to the same measure following each control drug given alone (Lorazepam, Loxapine)
Measured: 24 hours

Secondary outcomes (6)

Relative Pharmacodynamic Effect on Systolic Blood Pressure for Combined vs Individual (Lorazepam, Loxapine)
LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for systolic blood pressure following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone
Measured: 24 hours
Relative Pharmacodynamic Effect on Sedation for Combined vs Individual (Lorazepam, Loxapine)
LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for sedation based on a 100 mm Visual Analog Scale (VAS) ranging from (0=sleepy to 100=wide awake) following administration of Lorazepam+Loxapine compared to the same measure following each control drug given alone (Lorazepam, Loxapine)
Measured: 24 hours
Relative Pharmacodynamic Effect on Pulse Oximetry for Combined vs Individual (Lorazepam, Loxapine)
LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for pulse oximetry following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone
Measured: 24 hours
Relative Pharmacodynamic Effect on Heart Rate for Combined vs Individual (Lorazepam, Loxapine)
LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for heart rate following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone
Measured: 24 hours
Relative Pharmacodynamic Effect on Diastolic Blood Pressure for Combined vs Individual (Lorazepam, Loxapine)
LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for diastolic blood pressure following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone
Measured: 24 hours
Relative Pharmacodynamic Effect on Cogscreen Pathfinder Response for Combined vs Individual (Lorazepam, Loxapine)
LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for Cogscreen Pathfinder Response following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone
Measured: 24 hours

Timeline

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

Jun 2013Jul 2013

First posted14 Jun 2013 (estimated)
Study startJun 2013
Primary completionJul 2013
Study completionJul 2013

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 Healthy VolunteersStudies of the same condition, open and under way.
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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01877642
Sponsor's protocol ID: AMDC-204-402
Status last verified: Jul 2013
First submitted: 12 Jun 2013
Last updated: 13 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

Publications

Spyker DA, Cassella JV, Stoltz RR, Yeung PP. Inhaled loxapine and intramuscular lorazepam in healthy volunteers: a randomized placebo-controlled drug-drug interaction study. Pharmacol Res Perspect. 2015 Dec 17;3(6):e00194. doi: 10.1002/prp2.194. eCollection 2015 Dec.
PubMed 27022468

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?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ADASUVE®-Lorazepam Drug-Drug Interaction Study
ClinicalTrials.gov ID: NCT01877642
Acronym / sponsor ID: AMDC-204-402
Conditions: Healthy Volunteers
Keywords: ADASUVE, inhaled loxapine, drug drug interaction, lorazepam, acute treatment of agitation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Alexza Pharmaceuticals, Inc.
Study start: Jun 2013
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 14 Jun 2013 (estimated)
Results: Posted 13 Dec 2017

Clinical summary

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

This study will compare the safety and effects over time for giving both ADASUVE and lorazepam (intramuscular) compared to that of each agent given alone.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Open Label (lorazepam 1 mg + Inhaled loxapine 10 mg)	Other	Drug: Lorazepam 1 mg IM, Drug: Inhaled loxapine 10 mgInhaled Staccato loxapine 10 mg + IM lorazepam 1 mg to confirm tolerability of combined treatment
Treatment Sequence ABC	Other	Drug: Lorazepam 1 mg IM, Drug: Inhaled loxapine 10 mg, Drug: Inhaled Placebo, Drug: Placebo IMTreatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
Treatment Sequence ACB	Other	Drug: Lorazepam 1 mg IM, Drug: Inhaled loxapine 10 mg, Drug: Inhaled Placebo, Drug: Placebo IMTreatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
Treatment Sequence BCA	Other	Drug: Lorazepam 1 mg IM, Drug: Inhaled loxapine 10 mg, Drug: Inhaled Placebo, Drug: Placebo IMTreatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
Treatment Sequence BAC	Other	Drug: Lorazepam 1 mg IM, Drug: Inhaled loxapine 10 mg, Drug: Inhaled Placebo, Drug: Placebo IMTreatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
Treatment Sequence CAB	Other	Drug: Lorazepam 1 mg IM, Drug: Inhaled loxapine 10 mg, Drug: Inhaled Placebo, Drug: Placebo IMTreatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg
Treatment Sequence CBA	Other	Drug: Lorazepam 1 mg IM, Drug: Inhaled loxapine 10 mg, Drug: Inhaled Placebo, Drug: Placebo IMTreatment: A = Lorazepam 1 mg IM + inhaled placebo, B = Lorazepam 1 mg IM + inhaled loxapine 10 mg, C= Placebo IM + inhaled loxapine 10 mg

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Male and female subjects between the ages of 18 to 50 years, inclusive.
Body mass index (BMI) ≥18 and ≤32.
Subjects who are willing and able to comply with the study schedule and requirements, and stay at the CRU for 9 days.
Subjects who speak, read, and understand English and are willing and able to provide written informed consent on an IRB approved form prior to the initiation of any study procedures.
Subjects who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.

Key exclusion criteria (12 listed)

Subject history, which includes: any cardiovascular disease or disorder; asthma, chronic obstructive lung disease, or any use of an inhaler prescribed for wheezing or bronchospasm must be excluded; sleep apnea; acute narrow-angle glaucoma; any neurological, gastrointestinal, hepatic, renal, hematologic, endocrine and/or metabolic disease or disorder; psychiatric illness or mental disorder except for short term situational anxiety or depression of < 2 years duration; any substance abuse or addiction within the last 2 years; pregnancy within the past 6 months.
Subjects who have taken prescription or nonprescription medication within 7 days of Visit 2.
Subjects who have had an acute illness within the last 7 days of Visit 2.
Subjects who have a history of HIV positivity.
Subjects who test positive for alcohol or have a positive urine drug screen.

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
Lorazepam 1 mg IMAlso: Ativan 1 mg IMLorazepam 1 mg intramuscular	Drug	Open Label (lorazepam 1 mg + Inhaled loxapine 10 mg), Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA
Inhaled loxapine 10 mgAlso: ADASUVE 10 mgInhaled Staccato loxapine 10 mg	Drug	Open Label (lorazepam 1 mg + Inhaled loxapine 10 mg), Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA
Inhaled PlaceboAlso: Staccato PlaceboInhaler with no drug in it to mimic the ADASUVE inhaler	Drug	Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA
Placebo IMAlso: Salineintramuscular placebo to mimic lorazepam 1 mg IM	Drug	Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA

Primary outcome

Maximum Level of Sedation for Lorazepam 1 mg IM + ADASUVE 10 mg
Time frame: 24 hours
Determine the maximum level of sedation for Lorazepam 1 mg IM + ADASUVE 10 mg based on the 100 mm Visual Analog Scale (VAS) ranging from (0=sleepy to 100=wide awake)
Relative Pharmacodynamic Effect on Respiration Rate for Combined vs Individual (Lorazepam, Loxapine)
Time frame: 24 hours
LS Mean ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for respiration rate following administration of Lorazepam+Loxapine compared to the same measure following each control drug given alone (Lorazepam, Loxapine)

6 secondary outcomes

Relative Pharmacodynamic Effect on Systolic Blood Pressure for Combined vs Individual (Lorazepam, Loxapine)
Time frame: 24 hours
Relative Pharmacodynamic Effect on Sedation for Combined vs Individual (Lorazepam, Loxapine)
Time frame: 24 hours
Relative Pharmacodynamic Effect on Pulse Oximetry for Combined vs Individual (Lorazepam, Loxapine)
Time frame: 24 hours
Relative Pharmacodynamic Effect on Heart Rate for Combined vs Individual (Lorazepam, Loxapine)
Time frame: 24 hours
Relative Pharmacodynamic Effect on Diastolic Blood Pressure for Combined vs Individual (Lorazepam, Loxapine)
Time frame: 24 hours
Relative Pharmacodynamic Effect on Cogscreen Pathfinder Response for Combined vs Individual (Lorazepam, Loxapine)
Time frame: 24 hours

Results and safety

Results posted to the registry on 13 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open Label (Lorazepam 1 mg + Inhaled Loxapine 10 mg)	4	4
Treatment Sequence ABC	3	3
Treatment Sequence ACB	3	3
Treatment Sequence BCA	3	3
Treatment Sequence BAC	3	3
Treatment Sequence CAB	3	3
Treatment Sequence CBA	3	3

Primary outcome: Maximum Level of Sedation for Lorazepam 1 mg IM + ADASUVE 10 mg

Time frame: 24 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Open Label Group n = 4
Value	12.3 (6.65)

Population analysed: Open label population

Primary outcome: Relative Pharmacodynamic Effect on Respiration Rate for Combined vs Individual (Lorazepam, Loxapine)

Time frame: 24 hours. Geometric least squares mean (90% Confidence Interval). Unit: percentage of effect on control drug

Measure	Lorazepam+Loxapine / Lorazepam n = 18	Lorazepam+Loxapine / Loxapine n = 18
Value	94.3 (91.5 to 97.3)	97.3 (94.3 to 100)

Population analysed: Pharmacodynamics Population

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of first study treatment to 30 days after the last study treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open Label (Lorazepam 1 mg + Inhaled Loxapine 10 mg)	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Lorazepam 1 mg IM	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Lorazepam 1 mg IM + Inhaled Loxapine 10 mg	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Inhaled Loxapine 10 mg	0 of 18 (0%)	2 of 18 (11.1%)	0 of 18

Limitations and caveats (from the sponsor): The 1-mg IM lorazepam dose used in this study was lower than that used in some previous studies assessing the effects of concomitant administration of antipsychotics with up to 2-mg lorazepam for the treatment of agitation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27022468Spyker DA, Cassella JV, Stoltz RR, Yeung PP. Inhaled loxapine and intramuscular lorazepam in healthy volunteers: a randomized placebo-controlled drug-drug interaction study. Pharmacol Res Perspect. 2015 Dec 17;3(6):e00194. doi: 10.1002/prp2.194. eCollection 2015 Dec.
Individual participant dataSharing planned: Yes. IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

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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.

Randall R Stoltz, MD principal investigator

Medical Director, Covance-Evansville, Evansville, IN 47710

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lorazepam 1 mg IM and Inhaled loxapine 10 mg in people with Healthy Volunteers, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.

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 12 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 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 13 Dec 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?

Maximum Level of Sedation for Lorazepam 1 mg IM + ADASUVE 10 mg (time frame: 24 hours). 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 NCT01877642, 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 13 Dec 2017.