Status:
COMPLETED
Determine the Relationship Between Circadian Rhythms and Nocturnal Asthma
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Brief Summary
Asthma is a disease that affects the lungs. Symptoms include repeated episodes of wheezing, breathlessness, chest tightness, and nighttime or early morning coughing. Some people with asthma experience...
Detailed Description
Nocturnal worsening of asthma, frequently called NA, is a common problem among some people with asthma and one that leads to increased morbidity and mortality. It is still unknown why lung function wo...
Eligibility Criteria
Inclusion
- Inclusion Criteria for People with Asthma:
- A physician diagnosis of asthma, consistent clinical history, and either 1) airway hyperresponsiveness indicated by a 20% or greater decrease in forced expiratory volume at one second (FEV1) in response to inhalation of methacholine at 8 mg/mL or less, or 2) bronchodilator-responsive expiratory airflow limitation (if FEV1 less than 70% of predicted value or less than 1.5 L, improving at least 200 mL and 12% in response to 180 μg of albuterol aerosol). Patients with NA should meet the above criteria and demonstrate an overnight decrease in peak flow of 20% or greater on at least four of seven nights at home.
- Inclusion Criteria for all Participants:
- Able to follow directions
- Exclusion Criteria for Participants with Asthma:
- Use of oral steroids within 2 weeks of study entry
- Use of cromolyn, leukotriene antagonist, or theophylline within 1 week of study entry
- History of cognitive or other neurological disorder
- Active symptoms of Diagnostic and Statistical Manual IV (DSM-IV) criteria for any major psychiatric disorder, alcohol abuse, or substance abuse
- History of, or concurrent, unstable or serious medical illness
- Shift work
- History or evidence of chronic obstructive pulmonary disease (COPD)
- Tobacco smoking within the last month, or history of smoking greater than 5 pack-years
- Pregnancy or the desire to become pregnant during the study period
- Hematocrit less than 30
- Worsening or unstable asthma that requires use of a bronchodilator for more than four times a day
- Exclusion Criteria for all Participants:
- History of obstructive sleep apnea or a body mass index more than 36, or other sleep disorder as assessed by questioning or polysomnography (PSG)
- History of cognitive or other neurological disorder
- Currently meets DSM-IV criteria for any major psychiatric disorder, alcohol abuse, or substance abuse (as assessed by an interview)
- Concurrent unstable or serious medical illness (other than asthma)
- Current use of psychoactive medications, including antidepressants, anxiolytics, neuroleptics, anticonvulsants, hypnotics, and stimulant medications
- Shift work
- A daily caffeine intake greater than 4 cups per day
- Smoking
- Pregnancy or the desire to become pregnant during the study period
- Atrial fibrillation or paced heart rhythm
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00891189
Start Date
January 1 2009
End Date
December 1 2011
Last Update
September 23 2016
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611