Trial Outcomes & Findings for Induced Sputum Study (0000-065) (NCT NCT00623714)

NCT ID: NCT00623714

Last Updated: 2015-05-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 13 participants
• Primary outcome timeframe: Baseline and 24 hours post allergen challenge
• Results posted on: 2015-05-05

Participant Flow

First Patient Entered: 28-Jan-2008 Last Patient, Last Visit: 05-Mar-2009 1 site

Inclusion * Mild/moderate allergic asthma * Allergic to house, dust, mite allergen * Early and late allergic response to inhaled allergen challenge Randomized sequence of treatments including 500 μg fluticasone or placebo in treatment periods 1 & 2. Treatment was twice a day (b.i.d.) for total of 5 doses over 3-day period.

Participant milestones

Measure	Placebo Then Fluticasone Days 1-2 Placebo twice a Day (b.i.d.) + Day 3 Placebo single dose, Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose	Fluticasone Then Placebo Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose, Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
Period 1 STARTED	6	7
Period 1 COMPLETED	6	7
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	6	7
Period 2 COMPLETED	6	7
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Induced Sputum Study (0000-065)

Baseline characteristics by cohort

Measure	All Patients n=13 Participants All Randomized Patients
Age, Continuous	25.9 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 24 hours post allergen challenge

Population: All Patients as Treated

Outcome measures

Measure	Placebo n=13 Participants Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose	Fluticasone n=13 Participants Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL)	2.57 pg/mL Interval 1.37 to 4.84	0.87 pg/mL Interval 0.46 to 1.64

SECONDARY outcome

Timeframe: Baseline and 24 hours post allergen challenge

Population: All Patients as Treated

Outcome measures

Measure	Placebo n=13 Participants Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose	Fluticasone n=13 Participants Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
Hour 24 Fold Change From Period Baseline in Interleukin-13 (IL-13) Protein Concentration (pg/mL)	2.11 pg/mL Interval 1.41 to 3.17	0.85 pg/mL Interval 0.57 to 1.28

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Fluticasone

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=13 participants at risk Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose	Fluticasone n=13 participants at risk Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
General disorders Fatigue	7.7% 1/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	15.4% 2/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Infections and infestations Nasopharyngitis	7.7% 1/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Infections and infestations Rhinitis	7.7% 1/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Infections and infestations Urinary Tract Infection	7.7% 1/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Nervous system disorders Headache	15.4% 2/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	15.4% 2/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Nervous system disorders Muscle Contractions Involuntary	7.7% 1/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	7.7% 1/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	7.7% 1/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	7.7% 1/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	7.7% 1/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	7.7% 1/13 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Results disclosure agreements

• Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER