Asthma Respiratory Asthma
Conditions
Interventions
This is a single-arm study in which asthmatic patients received doxofylline 400 mg (Maxivent 400 mg, tablets
Lot # Dox-049-11/E) three times daily (t.i.d, drug administered at 8 hr interval) administered per os. The total duration of treatment was 12 months, and the follow up lasted 13 months
Sponsors
Roberts Pharmaceutical Corporation
ABC farmaceutici
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and non-pregnant females. 1.1. Women of childbearing potential had to use acceptable methods of birth control and have a negative prestudy serum ß-hCG pregnancy test. 1.1.1. Acceptable methods of birth control were limited to vaginal or intrauterine contraceptive devices or agents and natural (postmenopausal) or surgical sterility. 2. 18 years of age or older. 3. Nonsmokers for at least 6 months before entering the study. 4. In good physical condition with a more than 1-year history of chronic, extrinsic reversible hyperreactive airway disease (asthma). 5. On screening, had a baseline FEV1 value within 50% to 80% of the predicted FEV1 value for their age and height, when immediate-release theophylline or sustained-release theophylline had been withheld for at least 24 hours. 6. On screening, at least a 15% increase in FEV1 30 minutes after administration of a standard dose (2 puffs, 180 µg) of albuterol. 7. Stable dose of inhaled corticosteroids (ICS) and/or cromolyn sodium for at least 30 days was permitted. If ICS and/or cromolyn sodium was required during the study, it was recommended that a Doxofylline baseline level be achieved (minimum, 14 days) before the administration of any additional medications.
Exclusion criteria
Exclusion criteria: 1. Clinically significant deviation from normal in physical examination, laboratory parameters, ECG, or chest x-ray, as evaluated by the Principal Investigator, that would have precluded the subject’s participation in the study 2. Clinically significant coexisting disease, including: 2.1. Cardiovascular disease, including a history of congestive heart failure, angina pectoris, or myocardial infarction within 1 year 2.2. Convulsive disorder 2.3. Gastrointestinal disease 2.4. Renal disease 2.5. Hepatic disease 2.6. Hematologic disease 2.7. Insulin-dependent diabetes mellitus 2.8. Nonreversible chronic pulmonary disease 2.9. Known infection with human immunodeficiency virus 2.10. Chronic obstructive pulmonary disease 3. Presence of any acute illness 4. Sensitivity to theophylline or theophylline-like agents 5. A resting heart rate of less than 50 bpm or greater than 100 bpm and/or an arterial blood pressure of less than 100/60 mmHg or greater than 140/90 mmHg when sitting 6. History of alcohol, narcotic, barbiturate, marijuana, or polydrug abuse 7. Participation in other investigational drug studies within 30 days before the start of this study, except the DOROTHEO1 (ISRCTN65297911) and DOROTHEO2 (ISRCTN22374987) that preceded this study. 8. Subjects using oral steroids or oral B2-agonists 9. Lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Airway obstruction is measured using “FEV1, detected via pulmonary” function tests at day 1 and months 1, 3, 6, 9, 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change from baseline (T0, hour 0) in FEV1 values is measured “via pulmonary function tests” at months 1, 3, 6, 9 and 12. 2. Asthma events rate (total number of events divided by the total number of days on study medication), and albuterol use rate (total number of puffs divided by total number of days on study medication) are determined using Medication/Symptom Diaries at “months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12.” 3. Safety is assessed by physical examinations, ECGs, and the recording of vital signs, laboratory test results, and adverse events “(AE) at months 1, 3, 6, 9 and 12.” 3.1. All “clinical AE” entered on the Case Report Forms (CRFs) are classified as to possible relation to study medication (not related, possibly related, definitely related, or unknown) and severity (mild, moderate, or severe). 3.2. Also recorded for each AE are the start and stop dates, the action taken (none, study medication discontinued, or treatment prescribed), and the outcome (recovered, recovered with sequelae, under treatment, deceased, unknown, or ongoing). 3.3. If a subject experiences an AE leading to withdrawal from the study, the investigator is to make an effort to have the subject return to the study centre for examination and obtain a serum sample for drug level determination. The time and date of the last dose taken is to be entered into the CRF. | — |
Countries
United States of America
Outcome results
None listed