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

NCT00801684 | Completed Phase 2 Results

• 1 other identifier: ALK27-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; pulmonary; inhalation

Outcome Measures

Primary Outcomes (1)

• 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.

  15 minutes to 24 hours post-treatment

Secondary Outcomes (2)

• FEV1 Response to Treatment

  Up to 24 hours post-treatment

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

  up to 24 hours post-treatment

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Represents Dose A in the Dosing Sequence assignments.

Drug: Placebo

TrIP-2D (100mcg)

EXPERIMENTAL

Represents Dose B

Drug: TrIP-2D

TrIP-2SS (100mcg)

EXPERIMENTAL

Represents Dose C

Drug: TrIP-2SS

TrIP-2D (400mcg)

EXPERIMENTAL

Represents Dose D

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.

Drug: TrIP-2SS + Foradil

Interventions

Placebo DRUG

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

Placebo

TrIP-2D DRUG

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-2D (100mcg)

TrIP-2SS DRUG

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-2SS (100mcg)

TrIP-2SS + Foradil DRUG

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.

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (1)

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Bernard L. Silverman, MD
• Organization: Alkermes, Inc.

bernard.silverman@alkermes.com

781-609-6000

Study Officials

• Bernard L. Silverman, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: February 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 19, 2011
• Results First Posted: May 10, 2011

Record last verified: 2011-05

Locations

US (1)