Trial Outcomes & Findings for An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma (NCT NCT02219048)

NCT ID: NCT02219048

Last Updated: 2019-06-12

Results Overview

Asthma worsening was defined as one of the following events: greater than or equal to (\>=) 30% reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; \>=6 additional rescue puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; deterioration of asthma (as determined by the Investigator) requiring systemic steroid treatment, an increase in inhaled corticosteroids \>=4 times the last dose received prior to discontinuation from the study, or hospitalization due to asthma.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: Baseline up to follow-up period (Week 16)
• Results posted on: 2019-06-12

Participant Flow

Participant milestones

Measure	Placebo Twice Daily Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
Overall Study STARTED	26	25
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	21	21

Reasons for withdrawal

Measure	Placebo Twice Daily Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
Overall Study Adverse Event	2	5
Overall Study No longer meets eligibility criteria	1	0
Overall Study Study terminated by sponsor	16	15
Overall Study Withdrawal by Subject	2	0
Overall Study Other	0	1

Baseline Characteristics

An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma

Baseline characteristics by cohort

Measure	Placebo Twice Daily n=26 Participants Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily n=25 Participants Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	Total n=51 Participants Total of all reporting groups
Age, Continuous	42.3 years STANDARD_DEVIATION 14.1 • n=5 Participants	44.2 years STANDARD_DEVIATION 10.0 • n=7 Participants	43.2 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to follow-up period (Week 16)

Population: The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo.

Asthma worsening was defined as one of the following events: greater than or equal to (>=) 30% reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; >=6 additional rescue puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; deterioration of asthma (as determined by the Investigator) requiring systemic steroid treatment, an increase in inhaled corticosteroids >=4 times the last dose received prior to discontinuation from the study, or hospitalization due to asthma.

Outcome measures

Measure	Placebo Twice Daily n=26 Participants Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily n=25 Participants Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
Percentage of Participants With Asthma Worsening Events	11.5 percentage of participants	16.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to follow-up period (Week 16)

Population: The modified intent-to-treat (mITT) analysis set initially included all randomized participants who received at least 1 dose of PF-03715455 or placebo. Only 7 participants (4 in PF-03715455 and 3 in placebo) were included in the presented descriptive analysis, since other observations were censored by study termination.

The time post randomization that the first asthma worsening event occurred (defined above).

Outcome measures

Measure	Placebo Twice Daily n=3 Participants Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily n=4 Participants Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
Time to Asthma Worsening Event	58 days Interval 35.0 to 82.0	19.5 days Interval 2.0 to 84.0

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, and Week 4

Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.

FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Baseline was defined as the latest measurement before first dosing.

Outcome measures

Measure	Placebo Twice Daily n=26 Participants Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily n=25 Participants Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Baseline	2.084 liters Standard Deviation 0.4645	2.158 liters Standard Deviation 0.4917
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline at Week 1	0.188 liters Standard Deviation 0.3941	0.111 liters Standard Deviation 0.2226
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline at Week 2	0.244 liters Standard Deviation 0.3797	0.107 liters Standard Deviation 0.1959
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline at Week 3	0.273 liters Standard Deviation 0.3444	0.124 liters Standard Deviation 0.2140
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline at Week 4	0.234 liters Standard Deviation 0.3251	0.148 liters Standard Deviation 0.2217

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, and Week 4

Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.

FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.

Outcome measures

Measure	Placebo Twice Daily n=26 Participants Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily n=25 Participants Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
Change From Baseline in Forced Vital Capacity (FVC) Baseline	3.393 liters Standard Deviation 0.8966	3.384 liters Standard Deviation 0.8958
Change From Baseline in Forced Vital Capacity (FVC) Change at Week 1	0.140 liters Standard Deviation 0.3866	0.042 liters Standard Deviation 0.2401
Change From Baseline in Forced Vital Capacity (FVC) Change at Week 2	0.243 liters Standard Deviation 0.3813	0.066 liters Standard Deviation 0.2321
Change From Baseline in Forced Vital Capacity (FVC) Change at Week 3	0.252 liters Standard Deviation 0.3053	0.020 liters Standard Deviation 0.2784
Change From Baseline in Forced Vital Capacity (FVC) Change at Week 4	0.178 liters Standard Deviation 0.3028	0.080 liters Standard Deviation 0.3136

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, and Week 4

Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.

FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration.

Outcome measures

Measure	Placebo Twice Daily n=26 Participants Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily n=25 Participants Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) Baseline	3.175 liters Standard Deviation 0.7707	3.150 liters Standard Deviation 0.7546
Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) Change at Week 1	0.134 liters Standard Deviation 0.3782	0.078 liters Standard Deviation 0.2401
Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) Change at Week 2	0.221 liters Standard Deviation 0.3603	0.072 liters Standard Deviation 0.1922
Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) Change at Week 3	0.264 liters Standard Deviation 0.3149	0.069 liters Standard Deviation 0.2569
Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6) Change at Week 4	0.178 liters Standard Deviation 0.2986	0.106 liters Standard Deviation 0.2664

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, and Week 4

Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.

Participants used a daily diary assessment to record overall asthma symptom scores twice a day (morning and evening). Questions included extent of albuterol use, symptoms of wheezing, breathlessness, chest tightness, and cough. The visit dependent asthma symptom scores were calculated based on the item in the daily diary assessment. A participant summarized her/his daily frequency of asthma symptoms during the last 24 hours by the assignment of an integer score (0,1,2,3 or 4). The score=0 value denoted the day without symptoms and the score=4 value denoted the day where symptoms occurred all of the time. The asthma symptom scores were calculated by averaging the values of the daily scores within visit-dependent time window. Higher score indicates asthma worsening

Outcome measures

Measure	Placebo Twice Daily n=26 Participants Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily n=25 Participants Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
Change From Baseline in Asthma Symptom Scores Change at Week 1	-0.14 units on a scale Standard Deviation 0.406	-0.12 units on a scale Standard Deviation 0.453
Change From Baseline in Asthma Symptom Scores Change at Week 2	-0.17 units on a scale Standard Deviation 0.497	-0.36 units on a scale Standard Deviation 0.560
Change From Baseline in Asthma Symptom Scores Baseline	1.15 units on a scale Standard Deviation 0.567	1.23 units on a scale Standard Deviation 0.636
Change From Baseline in Asthma Symptom Scores Change at Week 3	-0.15 units on a scale Standard Deviation 0.471	-0.44 units on a scale Standard Deviation 0.458
Change From Baseline in Asthma Symptom Scores Change at Week 4	-0.19 units on a scale Standard Deviation 0.565	-0.38 units on a scale Standard Deviation 0.513

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, and Week 4

Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.

The number of nocturnal awakenings due to asthma symptoms was recorded by the participant.

Outcome measures

Measure	Placebo Twice Daily n=26 Participants Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily n=25 Participants Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
Number of Night Time Awakenings Per Week Baseline	2.03 night awakenings per week Standard Deviation 2.088	1.40 night awakenings per week Standard Deviation 1.925
Number of Night Time Awakenings Per Week Week 1	1.34 night awakenings per week Standard Deviation 2.101	1.38 night awakenings per week Standard Deviation 2.210
Number of Night Time Awakenings Per Week Week 2	1.39 night awakenings per week Standard Deviation 1.990	1.43 night awakenings per week Standard Deviation 2.251
Number of Night Time Awakenings Per Week Week 3	0.89 night awakenings per week Standard Deviation 1.657	1.66 night awakenings per week Standard Deviation 2.431
Number of Night Time Awakenings Per Week Week 4	1.04 night awakenings per week Standard Deviation 1.869	1.27 night awakenings per week Standard Deviation 1.830

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, and Week 4

Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.

The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. The changes from baseline (CFB) at each week and over 4 weeks were analyzed.

Outcome measures

Measure	Placebo Twice Daily n=26 Participants Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily n=25 Participants Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Morning PEF: Baseline	346.67 liters per minute Standard Deviation 92.666	361.46 liters per minute Standard Deviation 145.788
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Morning PEF: CFB at Week 1	17.42 liters per minute Standard Deviation 31.100	22.25 liters per minute Standard Deviation 41.585
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Morning PEF: CFB at Week 2	22.25 liters per minute Standard Deviation 38.822	29.80 liters per minute Standard Deviation 51.818
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Morning PEF: CFB at Week 3	18.86 liters per minute Standard Deviation 40.775	23.55 liters per minute Standard Deviation 42.129
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Morning PEF: CFB at Week 4	21.54 liters per minute Standard Deviation 41.697	22.65 liters per minute Standard Deviation 47.892
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Evening PEF: Baseline	357.86 liters per minute Standard Deviation 91.426	382.05 liters per minute Standard Deviation 130.316
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Evening PEF: CFB at Week 1	20.51 liters per minute Standard Deviation 33.868	20.14 liters per minute Standard Deviation 43.925
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Evening PEF: CFB at Week 2	20.70 liters per minute Standard Deviation 29.127	23.87 liters per minute Standard Deviation 40.435
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Evening PEF: CFB at Week 3	22.55 liters per minute Standard Deviation 35.234	17.74 liters per minute Standard Deviation 44.378
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Evening PEF: CFB at Week 4	19.10 liters per minute Standard Deviation 42.063	23.22 liters per minute Standard Deviation 48.329

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, and Week 4

Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.

The 5-question version of the Juniper ACQ is a validated questionnaire to evaluate asthma control. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of <= 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.

Outcome measures

Measure	Placebo Twice Daily n=26 Participants Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily n=25 Participants Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 Baseline	2.18 units on a scale Standard Deviation 0.315	2.17 units on a scale Standard Deviation 0.489
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 Change at Week 1	-0.50 units on a scale Standard Deviation 0.742	-0.27 units on a scale Standard Deviation 0.658
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 Change at Week 2	-0.66 units on a scale Standard Deviation 0.826	-0.53 units on a scale Standard Deviation 0.670
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 Change at Week 3	-0.62 units on a scale Standard Deviation 0.959	-0.34 units on a scale Standard Deviation 0.751
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4 Change at Week 4	-0.71 units on a scale Standard Deviation 0.838	-0.41 units on a scale Standard Deviation 0.806

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, and Week 4

Population: The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.

The use of rescue bronchodilators (albuterol or levalbuterol) for symptomatic relief of asthma in a 24-hour period was recorded by the participant.

Outcome measures

Measure	Placebo Twice Daily n=26 Participants Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily n=25 Participants Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
Number of Daily Puffs of Rescue Medication Week 4	1.34 puffs per day Standard Deviation 1.385	1.54 puffs per day Standard Deviation 2.264
Number of Daily Puffs of Rescue Medication Baseline	1.90 puffs per day Standard Deviation 1.364	1.96 puffs per day Standard Deviation 1.628
Number of Daily Puffs of Rescue Medication Week 1	1.51 puffs per day Standard Deviation 1.254	1.74 puffs per day Standard Deviation 2.164
Number of Daily Puffs of Rescue Medication Week 2	1.51 puffs per day Standard Deviation 1.431	1.07 puffs per day Standard Deviation 1.494
Number of Daily Puffs of Rescue Medication Week 3	1.48 puffs per day Standard Deviation 1.391	1.37 puffs per day Standard Deviation 1.772

Adverse Events

Placebo Twice Daily

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

PF-03715455 680 mcg Twice Daily

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo Twice Daily n=26 participants at risk Participants received placebo-matched PF-03715455 twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.	PF-03715455 680 mcg Twice Daily n=25 participants at risk Participants received PF-03715455 680 micrograms (mcg) twice a day for 12 weeks via oral inhalation using the Miat monodose inhaler.
Eye disorders Dry eye	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	0.00% 0/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Gastrointestinal disorders Gingival hypertrophy	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Gastrointestinal disorders Toothache	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
General disorders Fatigue	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
General disorders Influenza-like illness	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
General disorders Pain	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Acute sinusitis	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Bronchitis	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Conjunctivitis	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Gastroenteritis	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Gastroenteritis viral	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Influenza	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	0.00% 0/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Oral herpes	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	0.00% 0/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Respiratory tract infection	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	0.00% 0/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Skin infection	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Urinary tract infection	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Viral upper respiratory tract infection	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Injury, poisoning and procedural complications Fall	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Injury, poisoning and procedural complications Mouth injury	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	0.00% 0/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Investigations Blood creatine phosphokinase increased	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	0.00% 0/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Investigations Blood urine present	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	0.00% 0/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Investigations Forced expiratory volume decreased	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	0.00% 0/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Investigations Hepatic enzyme increased	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Musculoskeletal and connective tissue disorders Pain in extremity	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	0.00% 0/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Nervous system disorders Dizziness	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Nervous system disorders Dysgeusia	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	0.00% 0/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Nervous system disorders Headache	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	8.0% 2/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Nervous system disorders Migraine	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	0.00% 0/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Psychiatric disorders Middle insomnia	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Respiratory, thoracic and mediastinal disorders Cough	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Respiratory, thoracic and mediastinal disorders Nasal oedema	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	0.00% 0/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Respiratory, thoracic and mediastinal disorders Pharyngeal mass	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Respiratory, thoracic and mediastinal disorders Sinus congestion	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	4.0% 1/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Oral candidiasis	7.7% 2/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	12.0% 3/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Sinusitis	0.00% 0/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	8.0% 2/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Infections and infestations Upper respiratory tract infection	15.4% 4/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	0.00% 0/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Respiratory, thoracic and mediastinal disorders Asthma	11.5% 3/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	24.0% 6/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.8% 1/26 • Baseline up to 1 month after end-of-treatment visit (Week 12)	8.0% 2/25 • Baseline up to 1 month after end-of-treatment visit (Week 12)

Additional Information

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Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER