Phase 4
Completed N=11,679
SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.
Source: ClinicalTrials.gov NCT01475721 ↗Enrolled (actual)
11,679
Serious AEs
2.2%
Results posted
Jan 2016
Primary outcomePrimary: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) — 34; 33 Participants — p=0.003
Summary
The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.
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Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) |
34; 33 | 0.003 sig |
| PRIMARY Number of Participants Experiencing at Least One Asthma Exacerbation |
480; 597 | 0.203 |
| SECONDARY Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death |
34; 33; 0; 2; 0; 0 | — |
| SECONDARY Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation |
66; 84 | 0.123 |
| SECONDARY Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours |
0.90; 1.09 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Provided consent to participate in the study
- Male or female, 12 years of age and older
- Clinical diagnosis of asthma for at least 1 year prior to the randomization
- Clinic PEF of greater than or equal to 50% of predicted normal value
- Subject must be appropriately using one of the treatments for asthma listed in the protocol
- Subject must be able to complete the asthma control questionnaire, daily questions about asthma, and use a DISKUS inhaler
- Subject must have history of at least 1 asthma exacerbation including one of the following in the year prior to randomization:
- requiring treatment with systemic corticosteroids
- an asthma-related hospitalization
Exclusion Criteria
- History of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support
- Concurrent respiratory disease other than asthma
- Current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
- Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine
- Presence of a bacterial or viral respiratory infection that is not resolved at randomization
- An asthma exacerbation requiring systemic corticosteriods within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization
- More than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
- Subject must not meet unstable asthma severity criteria as listed in the protocol
- Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
- Pregnancy, breast-feeding or planned pregnancy during the study
- A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
Data sourced from ClinicalTrials.gov (NCT01475721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.