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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801684
• Other study ID #: ALK27-001
• Status: Completed
• Phase: Phase 2
• First received: December 2, 2008
• Last updated: August 17, 2011
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: May 2011
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Placebo
Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler.
• TrIP-2D
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
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
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 + Foradil
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.

Locations

Country	Name	City	State
United States	Spartanburg Medical Research	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	FEV1 Response to Treatment	Response was defined as the number of subjects reporting a post-treatment FEV1 of =12% (or 200 mL) above baseline.	Up to 24 hours post-treatment	No
Secondary	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.	up to 24 hours post-treatment	No