Study identifier:D6930C00017
ClinicalTrials.gov identifier:NCT05555290
EudraCT identifier:N/A
CTIS identifier:N/A
ALTA - ALbuterol/budesonide Treatment in Acute airway obstruction. A randomized, double-blind, 2-period, cross-over study evaluating efficacy and safety of repeated doses of PT027 compared to PT007 in patients with asthma and acute airway obstruction induced by repeated mannitol challenges
asthma
Phase 3
No
-
All
21
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
-
A study evaluating efficacy and safety of repeated doses of PT027 compared to PT007 in patients with asthma and acute airway obstruction induced by repeated mannitol challenges
This is a multi-center, randomized, double-blind, 2-period, cross-over study evaluating efficacy and safety of repeated doses of PT027 (albuterol/budesonide pressurized metered dose inhaler (pMDI)) compared to PT007 (albuterol pMDI) in participants with asthma and acute airway obstruction induced by 2 mannitol challenges at least 8 hours apart. It is a two-part study where Part 1 will enroll a small cohort of participants and will be used as a pilot study. The data obtained from Part 1 will be assessed by an internal AstraZeneca advisory board, and suggested changes may be made to Part 2 of the study. The following is the sequence of study visits: (i) Visit 1 (V1) screening (ii) Visit 2 (V2) 10 to 14 days after Visit 1 assessments; 1st dual challenge and treatment visit (iii) Visit 3 (V3) 10 to 14 days after Visit 2; 2nd dual challenge and treatment visit At Visit 1, all participants will be subjected to a single mannitol challenge to establish a positive response (defined as a ≥15% decrease in forced expiratory volume in the first second [FEV1] from the 0 mg mannitol FEV1 value) and will receive 4 puffs of open-label PT007. At Visit 2, participants will be randomized to one of 2 treatment sequences, A/B or B/A, where treatments A and B are defined as: (i) Treatment A = PT027 (ii) Treatment B = PT007 For treatment sequence A/B, participants will receive repeated inhalations of PT027 at Visit 2 followed by repeated inhalations of PT007 in Visit 3 . For treatment sequence B/A, participants will receive repeated inhalations of PT007 at Visit 2 followed by repeated inhalations of PT027 in Visit 3. Participants will have a Follow-up Telephone call 7 days after Visit 3/after Early discontinuation (ED).
Location
Location
Columbia, MD, United States, 21046
Arms | Assigned Interventions |
---|---|
Experimental: Treatment A (PT027) [experimental], then Treatment B (PT007) [active comparator] Part 1 & 2 At Visit 2, participants will receive repeated oral inhalations of PT027 to treat acute airway obstruction induced by a repeated airway challenge, followed by a washout period of 10-14 days. At Visit 3, participants will receive repeated oral inhalations of PT007 to treat acute airway obstruction induced by a repeated airway challenge. | Combination Product: PT027 When administered PT027, participants will receive 2 actuations of albuterol- budesonide per dose administered as oral inhalations. Combination Product: PT007 When administered PT007, participants will receive 2 actuations of albuterol administered as oral inhalations. |
Experimental: Treatment B (PT007) [active comparator], then Treatment A (PT027) [experimental] Part 1 & 2 At Visit 2, participants will receive repeated oral inhalations of PT007 to treat acute airway obstruction induced by a repeated airway challenge, followed by a washout period of 10 to 14 days. At Visit 3, participants will receive repeated oral inhalations of PT027 to treat acute airway obstruction induced by a repeated airway challenge. | Combination Product: PT027 When administered PT027, participants will receive 2 actuations of albuterol- budesonide per dose administered as oral inhalations. Combination Product: PT007 When administered PT007, participants will receive 2 actuations of albuterol administered as oral inhalations. |
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