Trial Outcomes & Findings for ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD (NCT NCT00801684)
NCT ID: NCT00801684
Last Updated: 2011-08-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
15 minutes to 24 hours post-treatment
Results posted on
2011-08-19
Participant Flow
Participant milestones
| Measure |
Overall Study
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. Doses A, B, C, and D were administered in a double-blind fashion. Dose E was administered in an open-label fashion.
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)
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD
Baseline characteristics by cohort
| Measure |
Overall Study
n=24 Participants
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. Doses A, B, C, and D were administered in a double-blind fashion. Dose E was administered in an open-label fashion.
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)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age Continuous
|
63.0 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes to 24 hours post-treatmentFollowing 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.
Outcome measures
| Measure |
TrIP-2SS (100mcg)
n=24 Participants
Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
|
TrIP-2SS (100mcg) + Foradil (12mcg)
n=24 Participants
Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
|
TrIP-2D (100mcg)
n=24 Participants
Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
|
TrIP-2D (400mcg)
n=24 Participants
Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
|
Placebo
n=24 Participants
Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
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|---|---|---|---|---|---|
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Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L)
|
1.707 Liters
Standard Deviation 0.528
|
1.696 Liters
Standard Deviation 0.521
|
1.672 Liters
Standard Deviation 0.528
|
1.676 Liters
Standard Deviation 0.516
|
1.508 Liters
Standard Deviation 0.545
|
SECONDARY outcome
Timeframe: Up to 24 hours post-treatmentPopulation: All 24 randomized subjects were included in the analysis.
Response was defined as the number of subjects reporting a post-treatment FEV1 of ≥12% (or 200 mL) above baseline.
Outcome measures
| Measure |
TrIP-2SS (100mcg)
n=24 Participants
Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
|
TrIP-2SS (100mcg) + Foradil (12mcg)
n=24 Participants
Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
|
TrIP-2D (100mcg)
n=24 Participants
Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
|
TrIP-2D (400mcg)
n=24 Participants
Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
|
Placebo
n=24 Participants
Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
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|---|---|---|---|---|---|
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FEV1 Response to Treatment
|
23 Participants
|
22 Participants
|
22 Participants
|
21 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: up to 24 hours post-treatmentPopulation: The PK population consisted of all subjects who received active study medication and had sufficient concentration data to facilitate calculation of the PK parameters or descriptive statistics of concentrations of trospium.
Tmax is reported as median (range) of hours to reach maximum trospium concentration in plasma.
Outcome measures
| Measure |
TrIP-2SS (100mcg)
n=12 Participants
Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
|
TrIP-2SS (100mcg) + Foradil (12mcg)
n=12 Participants
Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
|
TrIP-2D (100mcg)
n=12 Participants
Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
|
TrIP-2D (400mcg)
n=24 Participants
Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
|
Placebo
Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
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|---|---|---|---|---|---|
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Time to Maximum Plasma Concentration (Tmax) of Trospium After Single Administrations of TrIP
|
0.08 Hours
Interval 0.03 to 0.08
|
0.08 Hours
Interval 0.02 to 0.48
|
0.08 Hours
Interval 0.03 to 0.08
|
0.08 Hours
Interval 0.02 to 0.52
|
—
|
Adverse Events
Overall Study
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TrIP-2D (100mcg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TrIP-2SS (100mcg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TrIP-2D (400mcg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TrIP-2SS (100mcg) + Foradil (12mcg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Overall Study
n=24 participants at risk
|
TrIP-2D (100mcg)
n=24 participants at risk
Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
|
TrIP-2SS (100mcg)
n=24 participants at risk
Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
|
TrIP-2D (400mcg)
n=24 participants at risk
Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
|
TrIP-2SS (100mcg) + Foradil (12mcg)
n=24 participants at risk
Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
|
Placebo
n=24 participants at risk
Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
2/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
|
Gastrointestinal disorders
Toothache
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
|
General disorders
Oedema peripheral
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
|
Infections and infestations
Viral infection
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
4.2%
1/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
0.00%
0/24 • Adverse events were monitored continuously from the time the subject signed the consent form until the end of the last dosing period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No individual Investigator may publish results without written agreement from Alkermes. Should an Investigator wish to publish or present the data at a meeting, a copy of the manuscript or abstract must be provided to the Sponsor at least 30 days prior to the submission for review and approval. Any revisions will be negotiated in good faith by the Investigator and Sponsor.
- Publication restrictions are in place
Restriction type: OTHER