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ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo

TrIP-2D

TrIP-2SS

TrIP-2D

TrIP-2SS + Foradil

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, pulmonary, inhalation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Using long-term oxygen therapy
Female subjects who are pregnant or breastfeeding
Participating in another clinical trial

Sites / Locations

Spartanburg Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

TrIP-2D (100mcg)

TrIP-2SS (100mcg)

TrIP-2D (400mcg)

TrIP-2SS (100mcg) + Foradil (12mcg)

Arm Description

Represents Dose A in the Dosing Sequence assignments.

Represents Dose B

Represents Dose C

Represents Dose D

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

FEV1 Response to Treatment

Response was defined as the number of subjects reporting a post-treatment FEV1 of ≥12% (or 200 mL) above baseline.

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.

Full Information

NCT ID

NCT00801684

First Posted

December 2, 2008

Last Updated

August 17, 2011

Sponsor

Alkermes, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00801684

Brief Title

ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD

Official Title

Efficacy, Safety, Tolerability, and Pharmacokinetics of Trospium Inhalation Powder (TrIP) Administered to Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Alkermes, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, pulmonary, inhalation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Represents Dose A in the Dosing Sequence assignments.

Arm Title

TrIP-2D (100mcg)

Arm Type

Experimental

Arm Description

Represents Dose B

Arm Title

TrIP-2SS (100mcg)

Arm Type

Experimental

Arm Description

Represents Dose C

Arm Title

TrIP-2D (400mcg)

Arm Type

Experimental

Arm Description

Represents Dose D

Arm Title

TrIP-2SS (100mcg) + Foradil (12mcg)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler.

Intervention Type

Drug

Intervention Name(s)

TrIP-2D

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

TrIP-2SS

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

TrIP-2D

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

TrIP-2SS + Foradil

Intervention Description

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.

Primary Outcome Measure Information:

Title

Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L)

Description

Time Frame

15 minutes to 24 hours post-treatment

Secondary Outcome Measure Information:

Title

FEV1 Response to Treatment

Description

Response was defined as the number of subjects reporting a post-treatment FEV1 of ≥12% (or 200 mL) above baseline.

Time Frame

Up to 24 hours post-treatment

Title

Time to Maximum Plasma Concentration (Tmax) of Trospium After Single Administrations of TrIP

Description

Tmax is reported as median (range) of hours to reach maximum trospium concentration in plasma.

Time Frame

up to 24 hours post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Using long-term oxygen therapy Female subjects who are pregnant or breastfeeding Participating in another clinical trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernard L. Silverman, MD

Organizational Affiliation

Alkermes, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Spartanburg Medical Research

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

12. IPD Sharing Statement

Learn more about this trial

ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD

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