Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Spartanburg, South Carolina 29303


Purpose:

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).


Study summary:

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.


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


Study is Available At:


Original ID:

ALK27-001


NCT ID:

NCT00801684


Secondary ID:


Study Acronym:


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)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alkermes


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

5


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bernard L. Silverman, MD
Study Director
Alkermes

Study Dates

Start Date:February 2009
Completion Date:July 2009
Completion Type:Actual
Primary Completion Date:April 2009
Primary Completion Type:Actual
Verification Date:May 2011
Last Changed Date:August 17, 2011
First Received Date:December 2, 2008
First Results Date:March 18, 2011

Study Outcomes

Outcome Type: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
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:FEV1 Response to Treatment
Time Frame:Up to 24 hours post-treatment
Safety Issues:False
Description:Response was defined as the number of subjects reporting a post-treatment FEV1 of ≥12% (or 200 mL) above baseline.
Outcome Type:Secondary Outcome
Measure:Time to Maximum Plasma Concentration (Tmax) of Trospium After Single Administrations of TrIP
Time Frame:up to 24 hours post-treatment
Safety Issues:False
Description:Tmax is reported as median (range) of hours to reach maximum trospium concentration in plasma.

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler.
Arm Name:Placebo
Intervention Type:Drug
Name:TrIP-2D
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.
Arm Name:TrIP-2D (100mcg)
Intervention Type:Drug
Name:TrIP-2SS
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.
Arm Name:TrIP-2SS (100mcg)
Intervention Type:Drug
Name:TrIP-2D
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.
Arm Name:TrIP-2D (400mcg)
Intervention Type:Drug
Name:TrIP-2SS + Foradil
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.
Arm Name:TrIP-2SS (100mcg) + Foradil (12mcg)

Study Arms

Study Arm Type:Experimental
Arm Name:TrIP-2SS (100mcg) + Foradil (12mcg)
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.
Study Arm Type:Experimental
Arm Name:TrIP-2D (400mcg)
Description:Represents Dose D
Study Arm Type:Experimental
Arm Name:TrIP-2SS (100mcg)
Description:Represents Dose C
Study Arm Type:Experimental
Arm Name:TrIP-2D (100mcg)
Description:Represents Dose B
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Represents Dose A in the Dosing Sequence assignments.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Alkermes

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.