A three period study conducted at clinics in the US, Europe and South America to compare the effectiveness of different doses of a new investigational drug, GSK573719, with placebo (no active treatment) in subjects with mild asthma.
- Conditions
- AsthmaMedDRA version: 15.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
- Registration Number
- EUCTR2011-005244-95-PL
- Lead Sponsor
- GlaxoSmithKline Research and Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 336
Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the Investigator Brochure for GSK573719, a muscarinic receptor antagonist and Inhaled Fluticasone Furoate (GW685698), a glucocorticoid receptor agonist.
Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
Subjects eligible for enrolment in the study must meet all of the following criteria:
Informed consent: Subjects must give their signed and dated written informed consent to participate.
Type of Subject: Out-patients. However a sub-group of subjects from selected sites will remain in the clinic overnight at the end of each treatment period for serial safety, efficacy and PK blood and urine assessments over a 24 hour period.
Age: 18 years of age or older at Visit 1.
Diagnosis: diagnosis of asthma as defined by the National Institutes of Health [NIH, 2007] at least 6 months prior to Visit 1.
Gender: Male or Eligible Female, eligible being defined as of non-childbearing potential or childbearing potential using an acceptable method of birth control consistently and correctly, as defined by the following:
• Male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject
• Implants of levonorgestrel or etonogestrel
• Injectable progestogen
• Oral contraceptive (either combined or progestogen alone)
• Estrogenic vaginal ring
• Percutaneous contraceptive patches
• Any intrauterine device (IUD) with a documented failure rate of less than 1% per year.
• Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository)
• Male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository)
• Females of child-bearing potential must commit to complete abstinence from intercourse, throughout the study including the follow-up period when this is the female’s preferred and usual lifestyle
• Female subjects should not be enrolled if they are pregnant or lactating or if they plan to become pregnant during the time of study participation. A serum pregnancy test is required of all females and will be performed at the initial screening visit (Visit 1) and Visit 10 or Early Withdrawal. In addition, a urine pregnancy test will be performed as in the Table of Time and Events.
Severity of Disease: A best pre-bronchodilator AM FEV1 of 60% to 85% of the predicted normal value at the Visit 1 (screening) visit. Percent predicted normal values will be based upon:
• NHANES III (Hankinson, 1999) for the primary race/ethnicity of the subject, e.g Mexican-American, African-American/African heritage, Caucasian
• Multiethnic spirometric assessments (Hankinson, 2010) for the primary race/ethnicity of the subject,e.g Asian
Reversibility of Disease: Demonstrated by =12% and =200mL increase in FEV1 within 40 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol at Visit 1 screening.
Current Anti-Asthma Therapy: Subjects must demonstrate a need for regular use of a non-corticosteroid controller as shown by having or received a prescription for either of
Deviations from exclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety.
Therefore, adherence to the criteria as specified in the protocol is essential.
Subjects meeting any of the following criteria must not be enrolled in the study:
• History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 5 years.
• Asthma Exacerbation: A subject must not have a history of a severe asthma exacerbation within 4 weeks prior to Visit 1. A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (oral, or injection) for at least 3 days or an inpatient hospitalization or emergency
department visit due to asthma that required systemic corticosteroids.
• Respiratory Infection expected to affect the subject’s ability to participate in the study: Within 4 weeks prior to Visit 1 a subject has had a culturedocumented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved and has led to a change in asthma management or, in the opinion of the Investigator, is expected to
affect the subject’s asthma status or the subject’s ability to participate in the study.
•Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma.
• Tobacco Use. Current smoker or a smoking history of = 10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years].
Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
• Diseases Preventing Use of Anticholinergics: Diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the study investigator or GSK medical monitor would pose a safety risk with use of an inhaled anticholinergic.
• Other Concurrent Diseases/Abnormalities: A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study. Examples are outlined in the
study procedure manual. The investigator is encouraged to contact the study medical monitor if further clarification is warranted.
Please refer Protocol page number: 23 and 24.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method