ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | Drug: Placebo Drug: TrIP-2D Drug: TrIP-2SS Drug: TrIP-2SS + Foradil | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy, Safety, Tolerability, and Pharmacokinetics of Trospium Inhalation Powder (TrIP) Administered to Subjects With Chronic Obstructive Pulmonary Disease (COPD) |
- 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.
- 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.
- 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.
| Enrollment: | 24 |
| Study Start Date: | February 2009 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Represents Dose A in the Dosing Sequence assignments.
|
Drug: Placebo
Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler.
|
|
Experimental: TrIP-2D (100mcg)
Represents Dose B
|
Drug: 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.
|
|
Experimental: TrIP-2SS (100mcg)
Represents Dose C
|
Drug: 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.
|
|
Experimental: TrIP-2D (400mcg)
Represents Dose D
|
Drug: 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.
|
|
Experimental: TrIP-2SS (100mcg) + Foradil (12mcg)
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
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.
|
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.
Eligibility
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| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801684
| United States, South Carolina | |
| Spartanburg Medical Research | |
| Spartanburg, South Carolina, United States, 29303 | |
| Study Director: | Bernard L. Silverman, MD | Alkermes, Inc. |
More Information
| Responsible Party: | Bernard L. Silverman, MD / VP, Clinical Development, Alkermes, Inc. |
| ClinicalTrials.gov Identifier: | NCT00801684 History of Changes |
| Other Study ID Numbers: |
ALK27-001 |
| First Submitted: | December 2, 2008 |
| First Posted: | December 3, 2008 |
| Results First Submitted: | March 18, 2011 |
| Results First Posted: | May 10, 2011 |
| Last Update Posted: | August 19, 2011 |
| Last Verified: | May 2011 |
Keywords provided by Alkermes, Inc.:
|
COPD pulmonary inhalation |
Additional relevant MeSH terms:
|
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Aspiration Respiratory Tract Diseases Respiration Disorders Pathologic Processes Formoterol Fumarate Trospium chloride Triptorelin Pamoate Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents |
Respiratory System Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Parasympatholytics Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Urological Agents Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents |