Phase 2
Completed N=27
Randomised Study Comparing the Effects of Inhaled FF/GW642444M Combination, FF and GW642444M on an Allergen Induced Asthmatic Response
Source: ClinicalTrials.gov NCT01128595 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period — -0.731; -0.216; -0.188; -0.536 Liters
Summary
We propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist/ inhaled corticosteroid combination product and its components on protection from allergic triggers in asthma
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period |
-0.731; -0.216; -0.188; -0.536 | — |
| PRIMARY LAR: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period |
-0.466; 0.018; 0.018; -0.298 | — |
| PRIMARY Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period |
-1.091; -0.614; -0.826; -0.955 | — |
| PRIMARY EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period |
-0.560; -0.297; -0.386; -0.533 | — |
| SECONDARY Maximum Percent Change From Saline in FEV1 Between 0-2 Hrs, Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period |
-26.13; -10.43; -16.14; -18.35 | — |
| SECONDARY Provocative Concentration of Methacholine Estimated to Result in a 20% Reduction in FEV1 (PC20) on Day 22 of Each Treatment Period |
1.046; 2.500; 2.492; 0.387 | — |
Eligibility Criteria
Inclusion Criteria
- Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
- Females of non-child bearing potential.
- Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation
- Pre-bronchodilator FEV1 >70% of predicted at screening
- Subjects who are current non-smokers
- Methacholine challenge PC20 < 8 mg/mL at screening
- Screening allergen challenge demonstrates that the subject experiences an early asthmatic response
Exclusion Criteria
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- Subject is hypertensive at screening
- Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
- History of life-threatening asthma
- Symptomatic with hay fever at screening or predicted to have symptomatic hayfever
- Unable to abstain from short acting beta agonists
- Unable to abstain from antihistamines
- Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-asthma anti-rhinitis or hay fever medication
- The subject has participated in a study with a new molecular entity during the previous 3 months or has participated in 4 or more clinical studies in the previous 12 months
- undergoing allergen desensitisation therapy
Data sourced from ClinicalTrials.gov (NCT01128595). 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.