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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma; Diabetes Mellitus

Intervention: Inhaled Insulin (Drug); Subcutaneous Insulin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

Official title: Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Asthma: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Parallel-Group Comparative Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)

Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco)

Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)

Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)

Secondary outcome:

Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1)

Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)

Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1)

Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco)

Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)

Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol

Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1)

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

Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1)

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

Methacholine Challenge

Mean Weekly Morning and Evening Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1 Second (FEV1)

Mean Weekly Number of Puffs of Albuterol Used (Rescue Medication)

Number of Subjects With Step-up and Step-down Changes in Classification of Asthma Severity by Medication Usage

Step Classification of Asthma Severity by Medication Usage

Mean Weekly Asthma Symptom Scores

Incidence of Non-severe Asthma Exacerbations

Incidence of Severe Asthma Exacerbations

Number of Systemic Corticosteroid Rescues

Asthma Control as Measured by the Asthma Control Questionnaire©

Baseline Dyspnea Index (BDI)

Transition Dyspnea Index (TDI): Change in Total Score

Glycosylated Hemoglobin (HbA1c)

Fasting Plasma Glucose

Body Weight: Mean Baseline and Change From Baseline

Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)

Total Daily Long-Acting Insulin Dose Adjusted for Body Weight

Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)

Total Daily Short-Acting Insulin Dose Adjusted for Body Weight

Lipids: Median Change From Baseline to Last Observation

Hypoglycemic Event Rates

Severe Hypoglycemic Event Rates

Eligibility

Minimum age: 18 Years. Maximum age: 77 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin

- Mild intermittent or mild to moderate persistent asthma

Exclusion Criteria:

- Poorly controlled, unstable or steroid-dependent asthma, insulin pump therapy,

smoking

Locations and Contacts

Pfizer Investigational Site, San Jose, Costa Rica

Pfizer Investigational Site, Neuss 41460, Germany

Pfizer Investigational Site, Edmonton, Alberta T5J 3N4, Canada

Pfizer Investigational Site, Red Deer, Alberta T4N 6V7, Canada

Pfizer Investigational Site, Glendale, Arizona 85306, United States

Pfizer Investigational Site, Peoria, Arizona 85381, United States

Pfizer Investigational Site, Phoenix, Arizona 85004, United States

Pfizer Investigational Site, Phoenix, Arizona 85006, United States

Pfizer Investigational Site, Phoenix, Arizona 85016, United States

Pfizer Investigational Site, Tucson, Arizona 85715, United States

Pfizer Investigational Site, Jonesboro, Arkansas 72401, United States

Pfizer Investigational Site, Searcy, Arkansas 72143, United States

Pfizer Investigational Site, Victoria, British Columbia V8R 1J8, Canada

Pfizer Investigational Site, Berkeley, California 94705, United States

Pfizer Investigational Site, Beverly Hills, California 90211, United States

Pfizer Investigational Site, Fresno, California 93720, United States

Pfizer Investigational Site, Greenbrae, California 94904, United States

Pfizer Investigational Site, Huntington Beach, California 92648, United States

Pfizer Investigational Site, Los Angeles, California 90073, United States

Pfizer Investigational Site, Riverside, California 92506, United States

Pfizer Investigational Site, San Diego, California 92114, United States

Pfizer Investigational Site, San Diego, California 92116, United States

Pfizer Investigational Site, Tustin, California 92780, United States

Pfizer Investigational Site, Boulder, Colorado 80304, United States

Pfizer Investigational Site, Denver, Colorado 80206, United States

Pfizer Investigational Site, Denver, Colorado 80209, United States

Pfizer Investigational Site, Denver, Colorado 80220, United States

Pfizer Investigational Site, Waterbury, Connecticut 06708, United States

Pfizer Investigational Site, Newark, Delaware 19713, United States

Pfizer Investigational Site, Chiefland, Florida 32626, United States

Pfizer Investigational Site, Clearwater, Florida 33756, United States

Pfizer Investigational Site, Clearwater, Florida 33765, United States

Pfizer Investigational Site, Melbourne, Florida 32901, United States

Pfizer Investigational Site, Miami, Florida 33144, United States

Pfizer Investigational Site, West Palm Beach, Florida 33401, United States

Pfizer Investigational Site, West Palm Beach, Florida 33404, United States

Pfizer Investigational Site, Augusta, Georgia 30909, United States

Pfizer Investigational Site, Honolulu, Hawaii 96813, United States

Pfizer Investigational Site, Honululu, Hawaii 96814, United States

Pfizer Investigational Site, Chicago, Illinois 60611, United States

Pfizer Investigational Site, Normal, Illinois 61761, United States

Pfizer Investigational Site, Evansville, Indiana 47713, United States

Pfizer Investigational Site, Indianapolis, Indiana 46250, United States

Pfizer Investigational Site, Des Moines, Iowa 50314, United States

Pfizer Investigational Site, Dubuque, Iowa 52002, United States

Pfizer Investigational Site, Dubuque, Iowa 52001, United States

Pfizer Investigational Site, Wichita, Kansas 67203, United States

Pfizer Investigational Site, Bossier City, Louisiana 71111, United States

Pfizer Investigational Site, Winnipeg, Manitoba R3A 1R9, Canada

Pfizer Investigational Site, Winnipeg, Manitoba R3E 3P4, Canada

Pfizer Investigational Site, North Dartmouth, Massachusetts 02747, United States

Pfizer Investigational Site, Springfield, Massachusetts 01103, United States

Pfizer Investigational Site, Springfield, Massachusetts 01107, United States

Pfizer Investigational Site, Waltham, Massachusetts 02453, United States

Pfizer Investigational Site, Brooklyn Center, Minnesota 55430, United States

Pfizer Investigational Site, St. Louis, Missouri 63141, United States

Pfizer Investigational Site, Butte, Montana 59701, United States

Pfizer Investigational Site, Henderson, Nevada 89015, United States

Pfizer Investigational Site, Las Vegas, Nevada 89103, United States

Pfizer Investigational Site, Las Vegas, Nevada 89128, United States

Pfizer Investigational Site, North Las Vegas, Nevada 89032, United States

Pfizer Investigational Site, Albuquerque, New Mexico 87131-5666, United States

Pfizer Investigational Site, Buffalo, New York 14209, United States

Pfizer Investigational Site, New York, New York 10029, United States

Pfizer Investigational Site, Cincinnati, Ohio 45219, United States

Pfizer Investigational Site, Cincinnati, Ohio 45231, United States

Pfizer Investigational Site, Cincinnati, Ohio 45242, United States

Pfizer Investigational Site, Dayton, Ohio 45402, United States

Pfizer Investigational Site, Toledo, Ohio 43606, United States

Pfizer Investigational Site, Toledo, Ohio 43608, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73103, United States

Pfizer Investigational Site, Burlington, Ontario L7M 4Y1, Canada

Pfizer Investigational Site, London, Ontario N6A 4V2, Canada

Pfizer Investigational Site, Medford, Oregon 97504, United States

Pfizer Investigational Site, Portland, Oregon 97210, United States

Pfizer Investigational Site, Portland, Oregon 97219, United States

Pfizer Investigational Site, Lansdale, Pennsylvania 19446, United States

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15243, United States

Pfizer Investigational Site, Laval, Quebec H7T 2P5, Canada

Pfizer Investigational Site, Montreal, Quebec H1T 2M4, Canada

Pfizer Investigational Site, Sherbrooke, Quebec J1H 5N4, Canada

Pfizer Investigational Site, Porto Alegre, RS 90035-170, Brazil

Pfizer Investigational Site, Campinas, SP 13083-900, Brazil

Pfizer Investigational Site, Sao Paulo, SP 01244-030, Brazil

Pfizer Investigational Site, SP, Sao Paulo 04231-030, Brazil

Pfizer Investigational Site, Spartanburg, South Carolina 29303, United States

Pfizer Investigational Site, Spartanburg, South Carolina 29307, United States

Pfizer Investigational Site, Bartlett, Tennessee 38133, United States

Pfizer Investigational Site, Memphis, Tennessee 38119, United States

Pfizer Investigational Site, Nashville, Tennessee 37203, United States

Pfizer Investigational Site, Beaumont, Texas 77701, United States

Pfizer Investigational Site, Dallas, Texas 75231, United States

Pfizer Investigational Site, Houstan, Texas 77079, United States

Pfizer Investigational Site, Houston, Texas 77030, United States

Pfizer Investigational Site, Houston, Texas 77043, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, San Antonio, Texas 78237, United States

Pfizer Investigational Site, Norfolk, Virginia 23502, United States

Pfizer Investigational Site, Richmond, Virginia 23229, United States

Pfizer Investigational Site, Richmond, Virginia 23235, United States

Pfizer Investigational Site, Spokane, Washington 99204, United States

Pfizer Investigational Site, Spokane, Washington 99202, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: January 2003
Last updated: May 26, 2010

Page last updated: August 23, 2015

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