Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00430300
First received: January 30, 2007
Last updated: May 17, 2013
Last verified: May 2013
Results First Received: May 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: UK-432,097
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
UK-432,097 150 Mcg UK-432,097 150 microgram (mcg) capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide metered dose inhaler (MDI) 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
UK-432,097 450 Mcg UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
UK-432,097 1350 Mcg UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
Placebo Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.

Participant Flow:   Overall Study
    UK-432,097 150 Mcg     UK-432,097 450 Mcg     UK-432,097 1350 Mcg     Placebo  
STARTED     17     18     35     17  
COMPLETED     15     16     29     15  
NOT COMPLETED     2     2     6     2  
Adverse Event                 0                 2                 1                 1  
Withdrawal by Subject                 1                 0                 5                 0  
Laboratory abnormality                 1                 0                 0                 0  
Unspecified                 0                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
UK-432,097 150 Mcg UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
UK-432,097 450 Mcg UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
UK-432,097 1350 Mcg UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
Placebo Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
Total Total of all reporting groups

Baseline Measures
    UK-432,097 150 Mcg     UK-432,097 450 Mcg     UK-432,097 1350 Mcg     Placebo     Total  
Number of Participants  
[units: participants]
  17     18     35     17     87  
Age, Customized  
[units: participants]
         
45 to 64 Years     8     7     12     9     36  
Greater Than or Equal to (>=) 65 Years     9     11     23     8     51  
Gender  
[units: participants]
         
Female     5     5     9     6     25  
Male     12     13     26     11     62  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6   [ Time Frame: Pre-dose at Baseline, Week 6 ]

2.  Secondary:   Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8   [ Time Frame: Pre-dose at Baseline, Week 2, 4, 8 ]

3.  Secondary:   Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8   [ Time Frame: Pre-dose at Baseline, Week 2, 4, 6, 8 ]

4.  Secondary:   Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8   [ Time Frame: Pre-dose at Baseline, Week 2, 4, 6, 8 ]

5.  Secondary:   Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8   [ Time Frame: Pre-dose at Baseline, Week 2, 4, 6, 8 ]

6.  Secondary:   Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6   [ Time Frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6 ]

7.  Secondary:   Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6   [ Time Frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6 ]

8.  Secondary:   Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6   [ Time Frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6 ]

9.  Secondary:   Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6   [ Time Frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6 ]

10.  Secondary:   Change From Baseline in Post-Bronchodilator FEV1 at Week 6   [ Time Frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6 ]

11.  Secondary:   Change From Baseline in Post-Bronchodilator FEV6 at Week 6   [ Time Frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6 ]

12.  Secondary:   Change From Baseline in Post-Bronchodilator FVC at Week 6   [ Time Frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6 ]

13.  Secondary:   Change From Baseline in Post-Bronchodilator IC at Week 6   [ Time Frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6 ]

14.  Secondary:   Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6   [ Time Frame: Baseline, Week 2, 4, 6 ]

15.  Secondary:   Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8   [ Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 ]

16.  Secondary:   Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8   [ Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 ]

17.  Secondary:   Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8   [ Time Frame: Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 ]

18.  Secondary:   Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)   [ Time Frame: Week 6 ]

19.  Secondary:   Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)   [ Time Frame: Week 6 ]

20.  Other Pre-specified:   Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6   [ Time Frame: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4 ]

21.  Other Pre-specified:   Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6   [ Time Frame: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4 ]

22.  Other Pre-specified:   Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8   [ Time Frame: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up) ]

23.  Other Pre-specified:   Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8   [ Time Frame: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up) ]

24.  Other Pre-specified:   Change in Post-Study Drug Forced Expiratory Volume in 1 Second (FEV1) Compared to Pre-Study Drug Forced Expiratory Volume in 1 Second (FEV1) at Week 0, 1, 2, 4, and 6   [ Time Frame: Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated prematurely due to futility based on results of interim analysis.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00430300     History of Changes
Other Study ID Numbers: A3971013
Study First Received: January 30, 2007
Results First Received: May 17, 2013
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration