A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139659
First received: August 29, 2005
Last updated: May 26, 2010
Last verified: October 2009
Results First Received: October 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Asthma
Diabetes Mellitus
Interventions: Drug: Inhaled Insulin
Drug: Subcutaneous Insulin

  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
Subjects were recruited at 63 centers and participated in the study between 10 January 2003 and 22 October 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
544 subjects were screened for the study. Prior to randomization subjects completed a 3-week run-in period during which all subjects received subcutaneous insulin. Of 288 subjects randomized, only 286 received randomized treatment; one subject assigned to inhaled insulin received subcutaneous insulin, and 1 subject DC'd prior to treatment.

Reporting Groups
  Description
Inhaled Insulin Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous Insulin Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Participant Flow:   Overall Study
    Inhaled Insulin     Subcutaneous Insulin  
STARTED     146 [1]   141 [2]
COMPLETED     106     123  
NOT COMPLETED     40     18  
Adverse Event                 12                 1  
Lack of Efficacy                 1                 1  
Lost to Follow-up                 7                 3  
Reason not Specified                 6                 3  
Withdrawal by Subject                 14                 10  
[1] 1 subject randomized was DC'd prior to receiving inhaled insulin but received subcutaneous insulin
[2] 1 subject randomized DC'd before receiving subcutaneous insulin and is not included in # of subjects



  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
Inhaled Insulin Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous Insulin Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Total Total of all reporting groups

Baseline Measures
    Inhaled Insulin     Subcutaneous Insulin     Total  
Number of Participants  
[units: participants]
  146     141     287  
Age, Customized  
[units: participants]
     
18-25 years     12     8     20  
26-35 years     18     13     31  
36-45 years     23     25     48  
46-55 years     33     41     74  
56-65 years     40     37     77  
66-75 years     20     17     37  
Gender  
[units: participants]
     
Female     97     91     188  
Male     49     50     99  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52 ]

2.  Primary:   Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco)   [ Time Frame: Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52 ]

3.  Primary:   Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Baseline through Week 52 Last Observation Carried Forward (LOCF) ]

4.  Primary:   Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF) ]

5.  Secondary:   Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF) ]

6.  Secondary:   Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation carried Forward (LOCF) ]

7.  Secondary:   Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward ]

8.  Secondary:   Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco)   [ Time Frame: Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF) ]

9.  Secondary:   Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF) ]

10.  Secondary:   Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52 ]

11.  Secondary:   Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF) ]

12.  Secondary:   Change From Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in One Second (FEV1) Measured 10 and 60 Minutes After the First Daily Dose of Insulin   [ Time Frame: Baseline, Week 9, Week 51 ]

13.  Secondary:   Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF) ]

14.  Secondary:   Change From Baseline in Insulin Dose Responsiveness for Carbon Monoxide Diffusing Capacity (DLco) Measured 10 and 60 Minutes After the First Daily Dose of Insulin   [ Time Frame: Baseline, Week 9, Week 51 ]

15.  Secondary:   Methacholine Challenge   [ Time Frame: 1 to 2 days following Weeks -3 and -1 visits, and at Week 11, Week 50, and Week 52 (+5) ]

16.  Secondary:   Mean Weekly Morning and Evening Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Week -3 through Week 52 ]

17.  Secondary:   Mean Weekly Number of Puffs of Albuterol Used (Rescue Medication)   [ Time Frame: Daily: Baseline to end of study ]

18.  Secondary:   Number of Subjects With Step-up and Step-down Changes in Classification of Asthma Severity by Medication Usage   [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58 ]

19.  Secondary:   Step Classification of Asthma Severity by Medication Usage   [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58 ]

20.  Secondary:   Mean Weekly Asthma Symptom Scores   [ Time Frame: Baseline through end of study ]

21.  Secondary:   Incidence of Non-severe Asthma Exacerbations   [ Time Frame: 0 to 1 week to > 12 months ]

22.  Secondary:   Incidence of Severe Asthma Exacerbations   [ Time Frame: 0 to 1 Week to > 12 Months ]

23.  Secondary:   Number of Systemic Corticosteroid Rescues   [ Time Frame: Baseline through Week 52 ]

24.  Secondary:   Asthma Control as Measured by the Asthma Control Questionnaire©   [ Time Frame: Baseline, Weeks 4, 12, 26, 39, 52 ]

25.  Secondary:   Baseline Dyspnea Index (BDI)   [ Time Frame: run-in period ]

26.  Secondary:   Transition Dyspnea Index (TDI): Change in Total Score   [ Time Frame: Week 4, Week 12, Week 26, Week 39, Week 52 ]

27.  Secondary:   Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF) ]

28.  Secondary:   Fasting Plasma Glucose   [ Time Frame: Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF) ]

29.  Secondary:   Body Weight: Mean Baseline and Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 11, Week 12, Week 18, Wek 26, Week 39, Week 50, Week 51, Week 52, Week 52 Last Observation Carried Forward (LOCF) ]

30.  Secondary:   Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52 ]

31.  Secondary:   Total Daily Long-Acting Insulin Dose Adjusted for Body Weight   [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52 ]

32.  Secondary:   Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)   [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52 ]

33.  Secondary:   Total Daily Short-Acting Insulin Dose Adjusted for Body Weight   [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52 ]

34.  Secondary:   Lipids: Median Change From Baseline to Last Observation   [ Time Frame: Baseline to Last Observation ]

35.  Secondary:   Hypoglycemic Event Rates   [ Time Frame: 0 to 1 month to 11 to 12 months, and Overall ]

36.  Secondary:   Severe Hypoglycemic Event Rates   [ Time Frame: 0 to 1 month to 11 to 12 months, and Overall ]


  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
Data for some secondary endpoints were not tabulated or analyzed for this study and some concomitant medication data were not accurately recorded and tabulated due to lack of resources resulting from scaling down of Exubera® development.


  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.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00139659     History of Changes
Other Study ID Numbers: A2171028
Study First Received: August 29, 2005
Results First Received: October 21, 2009
Last Updated: May 26, 2010
Health Authority: United States: Food and Drug Administration