Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005484
Other study ID # 5000
Secondary ID R29HL048237
Status Completed
Phase N/A
First received May 25, 2000
Last updated February 17, 2016
Start date April 1992
Est. completion date March 1997

Study information

Verified date March 2004
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To identify clinical predictors of episodes of hospital-based care in people with asthma.


Description:

BACKGROUND:

This study was of great practical importance because asthma is a common condition (3-5 percent of the population) which has had a recent, unexplained rise in morbidity and mortality. Many previous epidemiological studies focused on predictors of hospitalization for people with asthma seen in the emergency room. These studies were of limited value for the practicing physician who sees the vast majority of patients with asthma.

Results from this study should, for the first time, enable a profile to be constructed of the high risk patient with asthma which includes identification of modifiable risk factors. These results can be used for physician and patient education programs as well as to target medical intervention.

DESIGN NARRATIVE:

The study developed a key piece of information needed for outpatient care of patients with asthma; a profile of patients at risk for severe, potentially life-threatening exacerbations of asthma. The experimental design was a prospective study of 800 patients with asthma drawn from a large, pre-paid health care plan. The key advantage of this population was that all the care occurred within the health plan. Characteristics identified included demographic factors, socioeconomic status; patient characteristics such as tobacco use, atopy, pattern of medication use, self-reporting of compliance/adherence, attitudes about asthma; historical assessment of indoor air quality; characteristics of asthma such as duration of asthma, lung function, and variation in asthma symptoms; and speciality of physician. The outcome measures were obtained over a three year period and included all episodes of hospital-based care including hospitalizations, emergency room visits, and urgency care clinic visits. Based on these data, models were developed which assigned relative risk to each of the independent variables. These models were validated in a subset of the population.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date March 1997
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (4)

Emery NL, Vollmer WM, Buist AS, Osborne ML. Self-reported food reactions and their associations with asthma. West J Nurs Res. 1996 Dec;18(6):643-54. — View Citation

Osborne ML, Vollmer WM, Linton KL, Buist AS. Characteristics of patients with asthma within a large HMO: a comparison by age and gender. Am J Respir Crit Care Med. 1998 Jan;157(1):123-8. — View Citation

Osborne ML, Vollmer WM, Pedula KL, Wilkins J, Buist AS, O'Hollaren M. Lack of correlation of symptoms with specialist-assessed long-term asthma severity. Chest. 1999 Jan;115(1):85-91. — View Citation

Sippel JM, Pedula KL, Vollmer WM, Buist AS, Osborne ML. Associations of smoking with hospital-based care and quality of life in patients with obstructive airway disease. Chest. 1999 Mar;115(3):691-6. — View Citation

See also
  Status Clinical Trial Phase
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device