Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus or Placebo
| Status: | Withdrawn |
|---|---|
| Conditions: | Allergy, Asthma |
| Therapuetic Areas: | Otolaryngology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 15 - 75 |
| Updated: | 6/17/2016 |
| Start Date: | April 2006 |
| End Date: | April 2007 |
A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray Versus Montelukast in Adolescents/Adults With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus(R) or Placebo
The four respiratory drugs being researched in this study have been approved by the US Food
and Drug Administration (FDA) and are currently available by prescription at your drug
store. One of the drugs is for the treatment of asthma alone, one is for treatment of SAR
alone, and one is for treatment of both SAR and asthma. In addition, you will also receive
one asthma rescue drug (albuterol) that is to be used for any breakthrough asthma symptoms
that you may experience throughout the study.
The purpose of this study is to see how well your asthma and SAR are controlled when taking
one of the medicine combinations
and Drug Administration (FDA) and are currently available by prescription at your drug
store. One of the drugs is for the treatment of asthma alone, one is for treatment of SAR
alone, and one is for treatment of both SAR and asthma. In addition, you will also receive
one asthma rescue drug (albuterol) that is to be used for any breakthrough asthma symptoms
that you may experience throughout the study.
The purpose of this study is to see how well your asthma and SAR are controlled when taking
one of the medicine combinations
4-week study to assess asthma control as measured by lung function and clinical features,
rhinitis treatment, subject-rated overall satisfaction with treatment, and safety outcomes
when FLONASE™ 200mcg (FPANS) QD, Singulair 10mg (MON) QD, or placebo QD is added to ADVAIR™
DISKUS™ 100/50mcg (FSC) BID and when Singulair 10mg (MON) QD is added to placebo DISKUS BID
in adolescent and adults subjects. Male or female subjects must be symptomatic with both
seasonal allergic rhinitis and persistent asthma, and have an FEV1 65-95% of predicted while
using an as-needed short-acting beta2-agonist or an allowed ICS or non-ICS controller
therapy. Subjects will replace their short-acting beta2-agonist with VENTOLIN™ HFA (for
rescue) and will enter a 7-14 day run-in period during which they will continue use of their
pre-study controller therapy. At Visit 2, subjects who meet both the asthma and rhinitis
randomization criteria will be randomized to double-blind treatment with ADVAIR DISKUS
100/50mcg BID and either FLONASE 200mcg QD, Singulair 10mg QD, or placebo QD, or to placebo
DISKUS BID and Singulair 10mg QD. The co-primary efficacy measures will be the mean change
from baseline at endpoint in AM PEF, compared between the FSC and the MON treatment groups
to assess superiority and compared between the FSC and FSC+MON treatment groups to assess
equivalence. Secondary efficacy measures for rhinitis will be mean change from baseline in
subject-rated daytime total nasal symptom score and nighttime total nasal symptomatic score
averaged over Weeks 1-2 (D-TNSSW1-2 and N-TNSSW1-2, respectively). Secondary efficacy
measures for asthma will be mean change from baseline at endpoint in morning pre-dose FEV1,
percentage of symptom-free days, and percentage of rescue-free days. Other measures will
include subject-rated overall satisfaction with treatment, evening PEF, asthma symptom
scores (D-INSSW1-x, N-INSSW1-2), averaged over Weeks 1-2. Descriptive measures will include
all total and individual nasal symptoms scores averaged over Weeks1-4. Safety measures will
include assessment of clinical adverse events and asthma exacerbations.
rhinitis treatment, subject-rated overall satisfaction with treatment, and safety outcomes
when FLONASE™ 200mcg (FPANS) QD, Singulair 10mg (MON) QD, or placebo QD is added to ADVAIR™
DISKUS™ 100/50mcg (FSC) BID and when Singulair 10mg (MON) QD is added to placebo DISKUS BID
in adolescent and adults subjects. Male or female subjects must be symptomatic with both
seasonal allergic rhinitis and persistent asthma, and have an FEV1 65-95% of predicted while
using an as-needed short-acting beta2-agonist or an allowed ICS or non-ICS controller
therapy. Subjects will replace their short-acting beta2-agonist with VENTOLIN™ HFA (for
rescue) and will enter a 7-14 day run-in period during which they will continue use of their
pre-study controller therapy. At Visit 2, subjects who meet both the asthma and rhinitis
randomization criteria will be randomized to double-blind treatment with ADVAIR DISKUS
100/50mcg BID and either FLONASE 200mcg QD, Singulair 10mg QD, or placebo QD, or to placebo
DISKUS BID and Singulair 10mg QD. The co-primary efficacy measures will be the mean change
from baseline at endpoint in AM PEF, compared between the FSC and the MON treatment groups
to assess superiority and compared between the FSC and FSC+MON treatment groups to assess
equivalence. Secondary efficacy measures for rhinitis will be mean change from baseline in
subject-rated daytime total nasal symptom score and nighttime total nasal symptomatic score
averaged over Weeks 1-2 (D-TNSSW1-2 and N-TNSSW1-2, respectively). Secondary efficacy
measures for asthma will be mean change from baseline at endpoint in morning pre-dose FEV1,
percentage of symptom-free days, and percentage of rescue-free days. Other measures will
include subject-rated overall satisfaction with treatment, evening PEF, asthma symptom
scores (D-INSSW1-x, N-INSSW1-2), averaged over Weeks 1-2. Descriptive measures will include
all total and individual nasal symptoms scores averaged over Weeks1-4. Safety measures will
include assessment of clinical adverse events and asthma exacerbations.
Inclusion Criteria:
- Signed and dated written informed consent is obtained.
- Male or female
- 15 Years and older
- Diagnosis of persistent asthma for at least three months.
- 3 months prior and current use of specified asthma therapies
- FEV1 between 65-95% of predicted value
- Diagnosis of seasonal allergic rhinitis
- Active residence within geographical regions where exposure to relevant seasonal
allergic is expected
Exclusion Criteria:
- Currently diagnosed with life-threatening asthma
- Asthma instability
- Concurrent respiratory disease
- Nasal obstruction
- Nasal history
- Certain concurrent conditions/diseases
- Drug allergy
- Respiratory tract infections
- Specific (listed in protocol) concurrent medications
- Systemic corticosteroids
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