HealthyPhase 1NCT00789360

Staccato Loxapine Pulmonary Safety in Healthy Volunteers

A Phase 1 study testing Inhaled Loxapine in people with Healthy, 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

The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Inhaled Loxapine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Nov 2008to Apr 2009
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

nonsmoker subjects in good general health with normal spirometry at screening AND baseline

Who cannot join

history of asthma, COPD, or any other acute or chronic pulmonary disease or bronchodilator use

Trial locations and contacts

1 site in 1 country.

United States1 site

Northeast Medical Research
North Dartmouth, Massachusetts, 02747

Other trials in United States

About this study

Official title: Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers

The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.

Read the detailed description

The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.

Conditions: Healthy
Being tested: Inhaled Placebo, Inhaled Loxapine
Keywords: Healthy volunteers

What participants receive

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

Inhaled PlaceboDrug
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
Inhaled LoxapineDrug
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart

Study groups in NCT00789360
Study group	Role	What they receive
Inhaled Placebo crossed over to Inhaled Loxapine	Experimental	Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; washout of at least 4 days; Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart Receives: Drug: Inhaled Placebo; Drug: Inhaled Loxapine
Inhaled Loxapine crossed over to Inhaled Placebo	Experimental	Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart; washout of at least 4 days; Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; Receives: Drug: Inhaled Placebo; Drug: Inhaled Loxapine

What is being measured

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

The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry
The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FEV1 Change from Same-Period Baseline,
Measured: 17 post-treatment time points (15 min to 32 hr)

Secondary outcomes (1)

The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry
The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FVC Change from Same-Period Baseline
Measured: 17 post-treatment time points (15 min to 32 hr)

Timeline

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

Nov 2008Apr 2009

First posted11 Nov 2008 (estimated)
Study startNov 2008
Primary completionApr 2009
Study completionApr 2009

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 HealthyStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00789360
Sponsor's protocol ID: AMDC-004-104
Other IDs: 12 September 2008
Status last verified: May 2009
First submitted: 7 Nov 2008
Last updated: 11 Mar 2019
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

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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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers
ClinicalTrials.gov ID: NCT00789360
Acronym / sponsor ID: AMDC-004-104
Conditions: Healthy
Keywords: Healthy volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Alexza Pharmaceuticals, Inc.
Study start: Nov 2008
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 11 Nov 2008 (estimated)
Results: Posted 11 Mar 2019

Clinical summary

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

The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.

Detailed description

The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Inhaled Placebo crossed over to Inhaled Loxapine	Experimental	Drug: Inhaled Placebo, Drug: Inhaled LoxapineInhaled Staccato Placebo, 2 inhalations, 8 hours apart; washout of at least 4 days; Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart
Inhaled Loxapine crossed over to Inhaled Placebo	Experimental	Drug: Inhaled Placebo, Drug: Inhaled LoxapineInhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart; washout of at least 4 days; Inhaled Staccato Placebo, 2 inhalations, 8 hours apart;

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

nonsmoker subjects in good general health with normal spirometry at screening AND baseline

Key exclusion criteria (1 listed)

history of asthma, COPD, or any other acute or chronic pulmonary disease or bronchodilator use

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
Inhaled PlaceboInhaled Staccato Placebo, 2 inhalations, 8 hours apart	Drug	Inhaled Loxapine crossed over to Inhaled Placebo, Inhaled Placebo crossed over to Inhaled Loxapine
Inhaled LoxapineInhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart	Drug	Inhaled Loxapine crossed over to Inhaled Placebo, Inhaled Placebo crossed over to Inhaled Loxapine

Primary outcome

The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry
Time frame: 17 post-treatment time points (15 min to 32 hr)
The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FEV1 Change from Same-Period Baseline,

1 secondary outcome

The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry
Time frame: 17 post-treatment time points (15 min to 32 hr)

Results and safety

Results posted to the registry on 11 Mar 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
Inhaled Placebo / Loxapine	15	12
Inhaled Loxapine / Placebo	15	14

Primary outcome: The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry

Time frame: 17 post-treatment time points (15 min to 32 hr). Least squares mean (90% Confidence Interval). Unit: liters

Measure	Inhaled Loxapine n = 23	Inhaled Staccato Placebo n = 25
Value	-0.1042 (-0.1776 to -0.0310)	-0.1025 (-0.18099 to -0.02393)

Inhaled Loxapine vs Inhaled Staccato Placebo: Maximum LS mean change difference: 0.0917 (90% CI -0.028 to 0.212)

Population analysed: Crossover Spirometry Population (all subjects receiving both inhaled loxapine and inhaled placebo) LSM and CI statistics were based on the individual (within subject) differences between loxapine and placebo exposures

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inhaled Placebo	1 of 29 (3.4%)	5 of 29 (17.2%)	0 of 29
Inhaled Loxapine	0 of 27 (0%)	16 of 27 (59.3%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

David S. Miller, MD principal investigator

Northeast Medical Research, North Dartmouth, MA

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Inhaled Loxapine in people with Healthy, 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 1 inclusion and 1 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 11 Mar 2019. 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 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 11 Mar 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?

The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry (time frame: 17 post-treatment time points (15 min to 32 hr)). 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 NCT00789360.

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 11 Mar 2019.