Chronic Obstructive Pulmonary DiseasePhase 1NCT00889837
Staccato Loxapine Pulmonary Safety in Patients With COPD
A Phase 1 study testing Inhaled Loxapine in people with Chronic Obstructive Pulmonary Disease, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the pulmonary safety of 2 doses of Staccato Loxapine within a day in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inhaled Loxapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of COPD for at least 6 months with pre-bronchodilator FEV1 ≥40% of predicted value and >15 pack-year history of cigarette smoking.
Who cannot join
- History of asthma, or any other acute or chronic pulmonary disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
About this study
Official title: Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Chronic Obstructive Pulmonary Disease
The purpose of this study is to assess the pulmonary safety of 2 doses of Staccato Loxapine within a day in patients with COPD.
Read the detailed description
To address the possibility that inhalation of loxapine may have adverse pulmonary effects, we studied two 10-mg inhaled doses of loxapine or placebo were given 10 hr apart to subjects with chronic obstructive pulmonary disease (COPD). The objective was to determine the time course and reversibility of pulmonary effects for inhaled loxapine compared with placebo.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Inhaled Loxapine, Inhaled Placebo
- Keywords
- Staccato Loxapine, COPD, pulmonary safety
- 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.
Inhaled LoxapineDrug
Staccato Loxapine, 10 mg x 2 doses, 10 hours apart
Inhaled PlaceboDrug
Staccato Placebo, inhalations x 2 , 10 hours apart
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Loxapine | Experimental | Staccato Loxapine, 10 mg doses x 2, 10 hours apart Receives: Drug: Inhaled Loxapine |
| Inhaled Placebo | Placebo comparator | Staccato Placebo,inhalations x 2, 10 hours apart Receives: Drug: Inhaled Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 from baseline by spirometry
Measured: at each post-treatment time point (15 min to 34 hr)
Secondary outcomes (2)
Change in FVC from baseline by spirometry
Measured: at each post-treatment time point (15 min to 34 hr)
Treatment emergent adverse events
Measured: Post-treatment time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Mildred D. Gottwald, PharmD, Study director, Alexza Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889837
- Sponsor's protocol ID
- AMDC-004-108
- Other IDs
- 13 April 2009
- Status last verified
- Aug 2009
- First submitted
- 27 Apr 2009
- Last updated
- 14 Mar 2017
- Results posted
- No
- 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
Gross N, Greos LS, Meltzer EO, Spangenthal S, Fishman RS, Spyker DA, Cassella JV. Safety and tolerability of inhaled loxapine in subjects with asthma and chronic obstructive pulmonary disease--two randomized controlled trials. J Aerosol Med Pulm Drug Deliv. 2014 Dec;27(6):478-87. doi: 10.1089/jamp.2013.1114.
PubMed 24745666
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00889837
- Acronym / sponsor ID
- AMDC-004-108
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Staccato Loxapine, COPD, pulmonary safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Not posted in the source record
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 assess the pulmonary safety of 2 doses of Staccato Loxapine within a day in patients with COPD.
Detailed description
To address the possibility that inhalation of loxapine may have adverse pulmonary effects, we studied two 10-mg inhaled doses of loxapine or placebo were given 10 hr apart to subjects with chronic obstructive pulmonary disease (COPD). The objective was to determine the time course and reversibility of pulmonary effects for inhaled loxapine compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Loxapine | Experimental | Drug: Inhaled LoxapineStaccato Loxapine, 10 mg doses x 2, 10 hours apart |
| Inhaled Placebo | Placebo comparator | Drug: Inhaled PlaceboStaccato Placebo,inhalations x 2, 10 hours apart |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History of COPD for at least 6 months with pre-bronchodilator FEV1 ≥40% of predicted value and >15 pack-year history of cigarette smoking.
Key exclusion criteria (1 listed)
- History of asthma, or any other acute or chronic pulmonary disease.
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 LoxapineStaccato Loxapine, 10 mg x 2 doses, 10 hours apart | Drug | Inhaled Loxapine |
| Inhaled PlaceboStaccato Placebo, inhalations x 2 , 10 hours apart | Drug | Inhaled Placebo |
Primary outcome
Change in FEV1 from baseline by spirometry
Time frame: at each post-treatment time point (15 min to 34 hr)
2 secondary outcomes
Change in FVC from baseline by spirometry
Time frame: at each post-treatment time point (15 min to 34 hr)
Treatment emergent adverse events
Time frame: Post-treatment time points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Background: PubMed 24745666Gross N, Greos LS, Meltzer EO, Spangenthal S, Fishman RS, Spyker DA, Cassella JV. Safety and tolerability of inhaled loxapine in subjects with asthma and chronic obstructive pulmonary disease--two randomized controlled trials. J Aerosol Med Pulm Drug Deliv. 2014 Dec;27(6):478-87. doi: 10.1089/jamp.2013.1114.
- 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.
Mildred D. Gottwald, PharmD study director
Alexza Pharmaceuticals, Inc.
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 Chronic Obstructive Pulmonary Disease, 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 14 Mar 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in FEV1 from baseline by spirometry (time frame: at each post-treatment time point (15 min to 34 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 NCT00889837, 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 14 Mar 2017.