A RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFECT OF THE ADDITION OF MONTELUKAST SODIUM OR SALMETEROL XINAFOATE TO INHALED FLUTICASONE IN ASTHMATIC ADULTS
- Conditions
- -J459 Asthma, unspecifiedAsthma, unspecifiedJ459
- Registration Number
- PER-016-99
- Lead Sponsor
- MERCK SHARP & DOHME PERÚ S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
a.Patient understands the study procedures and agrees to participate by signing the appropriate informed consent form.
b.Patient is a male or female and at least 15 and not more than 65 years of age at Visit 1. Female patients of childbearing potential must demónstrate a b-hCG level consistent with a non-gravid State at randomization and agree to use appropriate contraceptives (oral or single barrier); beginning at least 7 days before Visit 1 and continuing at least 14 days after Visit 9 or discontinuation visit.
c.Patient has been a regular user of inhaled corticosteroids at dosages for at least eight weeks before Visit 1 (Prestudy Visit).
d.Patient fulfills all the following signs and symptoms of asthma by Visit 3:
1) A consistent clinical history, at least one year in duration, of intermittent or persistent symptoms including, but not limited to dyspnea, wheezing, chest tightness, cough, or sputum production.
2) A forced expiratory volume in one second (FEVi), while withholding P-agonist for at least six hours, of between 50% and 90% (inclusive) of the predicted valué on at least two occasions at Visits 1, 2 or 3.
3) Evidence of reversible airway obstruction, as defíned by an increase in FEVi or peak expiratory flow rate of >12% (absolute value) of predicted, 20 to 30 minutes after inhaled p -agonist administration on at least one occasion at Visits 1, 2, 3 or within the previous 12 months.
4) A predetermined level of daytime symptoms (bi-weekly score of at least 56) and beta-agonist use (average of at least one puff/day) as recorded during the two weeks between Visits 2 and 3.
e.Patient´s present asthma treatment Includes only short-acting inhaled beta-agonists and inhaled corticosteroids at the prestudy visit.
f.Patient is currently a nonsmoker and has been a nonsmoker for at least six months prior to Visit 1, with a smoking history of no more than twelve pack-years [i.e., one pack (20 cigarettes) per day for twelve years].
g.Patient is judged to be in good, stable physical and mental health (except for his/her asthma) based on the medical history, physical examination, and routine laboratory data and appears able to successfully complete this trial.
General
a.Patient is under the age of legal consent and consent cannot be obtained from parent or guardián.
b.Patient is, in the opinión of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, or cannot read or comprehend written material.
c.Patient is hospitalized.
d.Patient is a female who is <8 weeks postpartum or is breast feeding an infant.
e.Patient intends to move or to vacation away from home for periods of time that would preclude their participation in the study.
f.Patient has undergone any major surgical procedure within four weeks of Visit 1.
g.Patient has participated in a clinical trial involving an investigational or marketed drug within four weeks of Visit 1.
h.Patient is currently a regular user or a recent past abuser (within the past five years), of alcohol or illicit drugs.
Pulmonary
i.Patient has, in addition to asthma, any active, acute or chronic pulmonary disorder documented by history or physical examination.
j.Patient has been treated in an emergency room within one month or has been hospitalized for asthma within three months of Visit 1.
k.Patient has unresolved symptoms and signs of an upper respiratory tract infection (URI) within three weeks of Visit 1 or during the run-in period.
l.Patient has evidence of active, clinically significant sinus infection (if previously present, it must have resolved within one week of Visit 1).
General Medical
m.Patient has a recent history (within three months of study start) of a clinically significant psychiatric disorder other than mild depression (does not interfere with work or social activities).
n.Patient has a history of an anaphyiactic allergic reaction related to administration of either a marketed or investigational dnig or is otherwise hypersensitive to inhaled p-agonist, inhaled or oral corticosteroid or their components.
o.Patient has a clinically significant, active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematological systems, or has uncontrolled hypertension (>160/95).
p.Patient has a history of any illness that would require treatment with an excluded medication, could be immediately Ufe threatening (ventricular arrhythmia, neoplasia, incompletely cured or treated in the last three months), ´brittle´ diabetes mellitus would pose restriction on participation or successful compietion of the study, or would pose an additional risk to the patient by administering the study drug.
q.Patient has significant and unexplained abnormalities on Period I laboratory measurements.
r.Patient is at least 40% over or under normal weight for height and body build (based upen the Metropolitan Life Insurance Co., Height and Weight Tables).
Medications
s.Patient has taken the following anti-asthma medication before Visit 1:
1) Oral, intravenous, intramuscular, cutaneous or intra-articular corticosteroids within one month
2) Cromolyn, nedocromil or leukotriene receptor antagonists within two weeks
3) TheophyIIine within one week
4) Oral or long acting inhaled beta-agonists or inhaled anticholinergic agents within two weeks
5) Terfenadine, fexofenadine, loratadine or cetirizine within one week (astemizole within 3 months).
t.Patient has taken any medication specifically excluded within 14 days of Vi
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method