Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT00801684
ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD
A Phase 2 study testing TrIP-2D, TrIP-2SS and TrIP-2SS + Foradil in people with Chronic Obstructive Pulmonary Disease (COPD), run by Alkermes, Inc. at 1 site in United States.
Trial summary
The purpose of this study was to evaluate the efficacy, safety, and tolerability of single doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- TrIP-2D, TrIP-2SS and TrIP-2SS + Foradil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2009
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female COPD subjects between the ages of 40 and 80 years
- Body mass index between 18 and 35
- Medically healthy (other than COPD)
- FEV1/FVC less than or equal to 0.70
- Current non-smoker or able to abstain from smoking for at least 8 hours postdose
- Within the previous 6 months, demonstrated improvement in FEV1 (greater than or equal to 10%) 1 hour following administration of ipratropium bromide inhalation (4 puffs)
- Females of childbearing potential must agree to use an acceptable method of contraception for the duration of the study
Who cannot join
- Asthma in the last 10 years
- Allergic rhinitis, atopy, cystic fibrosis, bronchiectasis, or tuberculosis
- Bladder neck obstruction, including urinary retention or known symptomatic prostatic hypertrophy not controlled with medication
- Narrow angle glaucoma
- Tachyarrhythmia
- Alcohol dependence or illicit drug abuse within the past year
Show all 9Show fewer
- Using long-term oxygen therapy
- Female subjects who are pregnant or breastfeeding
- Participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
About this study
Official title: Efficacy, Safety, Tolerability, and Pharmacokinetics of Trospium Inhalation Powder (TrIP) Administered to Subjects With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study was to evaluate the efficacy, safety, and tolerability of single doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive pulmonary disease (COPD).
Read the detailed description
This was a single-center, randomized, double-blind, cross-over, placebo-controlled study. Following screening, each eligible subject was randomized to a dosing sequence. Study subjects received a total of 5 single doses, each separated by a 3- to 14-day washout period. Doses A, B, C, and D were administered in a double-blind fashion, in sequences generated by a 4-period Latin square design. The 4 dosing sequences were: ABCD, BDAC, CADB, and DCBA. Dose E was administered in an open-label fashion as the final dose in each dosing sequence for all subjects.
Subjects reported to the clinic the evening prior to each dose. Protocol assessments were carried out until 24 hours postdose. Pulmonary function testing (via spirometry) was captured at specified timepoints at baseline as well as before and after dosing. Other efficacy and safety outcomes were assessed according to protocol. Blood sampling was performed for assessment of trospium concentrations at specified timepoints.
- Being tested
- Placebo, TrIP-2D, TrIP-2SS, TrIP-2SS + Foradil
- Keywords
- COPD, pulmonary, inhalation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler.
TrIP-2DDrug
Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.
TrIP-2SSDrug
Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.
TrIP-2DDrug
Trospium inhalation powder containing 400 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.
TrIP-2SS + ForadilDrug
Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), plus foradil (12 mcg formoterol fumarate) supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Represents Dose A in the Dosing Sequence assignments. Receives: Drug: Placebo |
| TrIP-2D (100mcg) | Experimental | Represents Dose B Receives: Drug: TrIP-2D |
| TrIP-2SS (100mcg) | Experimental | Represents Dose C Receives: Drug: TrIP-2SS |
| TrIP-2D (400mcg) | Experimental | Represents Dose D Receives: Drug: TrIP-2D |
| TrIP-2SS (100mcg) + Foradil (12mcg) | Experimental | Represents Dose E. All subjects received Dose E as their final (5th) dose, after completing their initial 4 single doses according to their sequence assignment. Receives: Drug: TrIP-2SS + Foradil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L)
Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval.
The dosing formulations were as follows:
Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate) FEV1 (L)was measured at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose.
Measured: 15 minutes to 24 hours post-treatment
Secondary outcomes (2)
FEV1 Response to Treatment
Response was defined as the number of subjects reporting a post-treatment FEV1 of ≥12% (or 200 mL) above baseline.
Measured: Up to 24 hours post-treatment
Time to Maximum Plasma Concentration (Tmax) of Trospium After Single Administrations of TrIP
Tmax is reported as median (range) of hours to reach maximum trospium concentration in plasma.
Measured: up to 24 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionApr 2009
- Study completionJul 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 Chronic Obstructive Pulmonary Disease (COPD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bernard L. Silverman, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801684
- Sponsor's protocol ID
- ALK27-001
- Status last verified
- May 2011
- First submitted
- 2 Dec 2008
- Last updated
- 19 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety, Tolerability, and Pharmacokinetics of Trospium Inhalation Powder (TrIP) Administered to Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00801684
- Acronym / sponsor ID
- ALK27-001
- Keywords
- COPD, pulmonary, inhalation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Posted 10 May 2011
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 was to evaluate the efficacy, safety, and tolerability of single doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive pulmonary disease (COPD).
Detailed description
This was a single-center, randomized, double-blind, cross-over, placebo-controlled study. Following screening, each eligible subject was randomized to a dosing sequence. Study subjects received a total of 5 single doses, each separated by a 3- to 14-day washout period. Doses A, B, C, and D were administered in a double-blind fashion, in sequences generated by a 4-period Latin square design. The 4 dosing sequences were: ABCD, BDAC, CADB, and DCBA. Dose E was administered in an open-label fashion as the final dose in each dosing sequence for all subjects.
Subjects reported to the clinic the evening prior to each dose. Protocol assessments were carried out until 24 hours postdose. Pulmonary function testing (via spirometry) was captured at specified timepoints at baseline as well as before and after dosing. Other efficacy and safety outcomes were assessed according to protocol. Blood sampling was performed for assessment of trospium concentrations at specified timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboRepresents Dose A in the Dosing Sequence assignments. |
| TrIP-2D (100mcg) | Experimental | Drug: TrIP-2DRepresents Dose B |
| TrIP-2SS (100mcg) | Experimental | Drug: TrIP-2SSRepresents Dose C |
| TrIP-2D (400mcg) | Experimental | Drug: TrIP-2DRepresents Dose D |
| TrIP-2SS (100mcg) + Foradil (12mcg) | Experimental | Drug: TrIP-2SS + ForadilRepresents Dose E. All subjects received Dose E as their final (5th) dose, after completing their initial 4 single doses according to their sequence assignment. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female COPD subjects between the ages of 40 and 80 years
- Body mass index between 18 and 35
- Medically healthy (other than COPD)
- FEV1/FVC less than or equal to 0.70
- Current non-smoker or able to abstain from smoking for at least 8 hours postdose
Key exclusion criteria (9 listed)
- Asthma in the last 10 years
- Allergic rhinitis, atopy, cystic fibrosis, bronchiectasis, or tuberculosis
- Bladder neck obstruction, including urinary retention or known symptomatic prostatic hypertrophy not controlled with medication
- Narrow angle glaucoma
- Tachyarrhythmia
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 |
|---|---|---|
| PlaceboSupplied as an empty size-2 capsule and administered as a single dose via C2S inhaler. | Drug | Placebo |
| TrIP-2DTrospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. | Drug | TrIP-2D (100mcg) |
| TrIP-2SSTrospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. | Drug | TrIP-2SS (100mcg) |
| TrIP-2DTrospium inhalation powder containing 400 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. | Drug | TrIP-2D (400mcg) |
| TrIP-2SS + ForadilTrospium inhalation powder containing 100 mcg TrCl (trospium chloride), plus foradil (12 mcg formoterol fumarate) supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. | Drug | TrIP-2SS (100mcg) + Foradil (12mcg) |
Primary outcome
Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L)
Time frame: 15 minutes to 24 hours post-treatment
Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. The dosing formulations were as follows: Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate) FEV1 (L)was measured at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose.
2 secondary outcomes
FEV1 Response to Treatment
Time frame: Up to 24 hours post-treatment
Time to Maximum Plasma Concentration (Tmax) of Trospium After Single Administrations of TrIP
Time frame: up to 24 hours post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
- 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.
Bernard L. Silverman, MD study director
Alkermes, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TrIP-2D, TrIP-2SS and TrIP-2SS + Foradil in people with Chronic Obstructive Pulmonary Disease (COPD), run by Alkermes, 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 9 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 19 Aug 2011. 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 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 May 2011). 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?
Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L) (time frame: 15 minutes to 24 hours post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2011.