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Completed

NCT Number: NCT00801684

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

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-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 + 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. FEV1 Response to Treatment

    Time frame: Up to 24 hours post-treatment

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

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

    Time frame: up to 24 hours post-treatment

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

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 3, 2008
Registry last updated
Aug 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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