Evaluation of the Pharmacokinetics and the Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 in Patients With Asthma

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01348139
• Collaborator: (none)
• Enrollment: 39
• Locations: 3
• Arms: 6
• Duration (Months): 9.1
• Patients Per Site: 13
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single doses of three different dry powder inhalation formulations of AZD3199 administered via Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler™ Inhaler and compared to placebo in patients with persistent asthma.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: AZD3199; Drug: AZD3199; Other: AZD3199 Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Multicentre, 6-way Crossover, Single-dose, Phase IIa Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 Administered Via Single Inhalation Device Compared to AZD3199 Administered Via Turbuhaler™ Inhaler in Patients With Asthma
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 AZD3199 800 µg inhaled via single inhaler device (SID), single dose	Drug: AZD3199; Inhaled via single inhaler device (SID)
Experimental: 2 AZD3199 880 µg inhaled via SID, single dose	Drug: AZD3199; Inhaled via single inhaler device (SID)
Experimental: 3 AZD3199 1400 µg inhaled via SID, single dose	Drug: AZD3199; Inhaled via single inhaler device (SID)
Experimental: 4 AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose	Drug: AZD3199; Inhaled via Turbuhaler inhaler
Experimental: 5 AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose	Drug: AZD3199; Inhaled via Turbuhaler inhaler
Placebo Comparator: 6 Placebo inhaled via Turbuhaler inhaler and SID, single dose	Other: AZD3199 Placebo; Inhaled via Turbuhaler inhaler and SID

Outcome Measures

Primary Outcome Measures

1. Emax: Maximum Value of FEV1 for Every Treatment Visits [0-24 hrs]

   Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.

2. E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit [22-26 hrs.]

   Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.

Secondary Outcome Measures

1. tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit [0 - 24 hrs.]

   Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.

2. E5min: The Value of FEV1 at 5 Min for Every Treatment Visit. [FEV1 at 5 min]

   Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.

3. E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit [0 - 24 hrs]

   Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.

4. Emax: Maximum Value of Pulse for Every Treatment Visits [0 - 4 hrs.]

   Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.

5. E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit [0 - 4 hrs.]

   Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.

6. Cmax: Maximum Plasma Concentration [0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.]

   Maximum plasma concentration (Cmax) for AZD3199 doses

7. AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC), [0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.]

   Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses

8. Tmax:Time to Maximum Plasma Concentration [0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.]

   Time to maximum plasma concentration (tmax), for AZD3199 doses

9. t1/2 :Terminal Half-life [0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.]

   Terminal half-life (t1/2),for AZD3199 doses

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Provision of signed and dated written informed consent prior to any study specific procedures

• Men or women, age ≥ 18 years. Women must be of non-childbearing potential or stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen contraceptive method throughout the study.

• Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to study start

• A history of asthma for at least 6 months.

• Body Mass Index (BMI) 19-30 kg/m2

Exclusion Criteria:

• Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study

• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to β2-agonists in general or to AZD3199 and/or excipients

• Prolonged QTcF > 450 msec or shortened QTcF <340 msec

• History of alcohol/drug abuse or excessive intake of alcohol as judged by the Investigator

• Pregnancy or lactation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Göteborg		Sweden
2	Research Site	Luleå		Sweden
3	Research Site	Lund		Sweden

Sponsors and Collaborators

• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01348139
• Other Study ID Numbers: D0570C00011; 2011-000133-37
• First Posted: May 5, 2011
• Last Update Posted: Mar 5, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by AstraZeneca: Asthma; patients; lung function
• Additional relevant MeSH terms: Asthma; AZD-3199

Study Results

Participant Flow

Recruitment Details	A total of 39 patients were enrolled at 3 centres in Sweden. Of these, 26 patients were randomised to receive a treatment sequence consisting of 6 different treatments in random order. The number of patients randomised was well balanced across all the treatment periods. In total, 25 patients completed the study.

Arm/Group Title	1400 μg / Placebo / 880 μg / 1200 μg / 800 μg / 300 μg	880 μg / 1400 μg / 800 μg / Placebo / 300 μg / 1200 μg	800 μg / 880 μg / 300 μg / 1400 μg / 1200 μg / Placebo	300 μg / 800 μg / 1200 μg / 880 μg / Placebo / 1400 μg	1200 μg / 300 μg / Placebo / 800 μg / 1400 μg / 880 μg	Placebo / 1200 μg / 1400 μg / 300 μg / 880 μg / 800 μg
Arm/Group Description	AZD3199 1400 μg SID followed by Placebo followed by AZD3199 880 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 300 μg Turbuhaler inhaler.	AZD3199 880 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 800 μg SID followed by Placebo followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1200 μg Turbuhaler inhaler.	AZD3199 800 μg SID followed by AZD3199 880 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by Placebo.	AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by Placebo followed by AZD3199 1400 μg SID.	AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 300 μg Turbuhaler inhaler followed by Placebo followed by AZD3199 800 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 880 μg SID.	Placebo followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by AZD3199 800 μg SID.
Period Title: Period 1
STARTED	5	4	4	4	5	4
COMPLETED	4	4	4	4	5	4
NOT COMPLETED	1	0	0	0	0	0
Period Title: Period 1
STARTED	4	4	4	4	5	4
COMPLETED	4	4	4	4	5	4
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1
STARTED	4	4	4	4	5	4
COMPLETED	4	4	4	4	5	4
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1
STARTED	4	4	4	4	5	4
COMPLETED	4	4	4	4	5	4
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1
STARTED	4	4	4	4	5	4
COMPLETED	4	4	4	4	5	4
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1
STARTED	4	4	4	4	5	4
COMPLETED	4	4	4	4	5	4
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Baseline Total
Arm/Group Description	Total number of patients randomised and treated in the study.
Overall Participants	26
Age (Years) [Mean (Standard Deviation) ]
All	36.5 (11.29)
Sex: Female, Male (Count of Participants)
Female	6 23.1%
Male	20 76.9%
Race/Ethnicity, Customized (Number) [Number]
White	24 92.3%
Asian	1 3.8%
Other	1 3.8%

Outcome Measures

1. Primary Outcome

Title	Emax: Maximum Value of FEV1 for Every Treatment Visits
Description	Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.
Time Frame	0-24 hrs

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1 - AZD3199 1400 μg	Arm 2 - AZD3199 880 μg	Arm 3 - AZD3199 800 μg	Arm 4 - AZD3199 300 μg	Arm 5 - AZD3199 1200 μg	Arm 6 - Placebo
Arm/Group Description	AZD3199 1400 μg SID	AZD3199 880 μg SID	AZD3199 800 μg SID	AZD3199 300 μg Turbuhaler inhaler	AZD3199 1200 μg Turbuhaler inhaler	Placebo
Measure Participants	25	25	25	25	25	25
Mean (Standard Deviation) [Liters]	3.788 (0.782)	3.784 (0.724)	3.756 (0.733)	3.763 (0.744)	3.847 (0.781)	3.498 (0.676)

2. Primary Outcome

Title	E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit
Description	Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.
Time Frame	22-26 hrs.

Outcome Measure Data

Analysis Population Description

PD analysis set

Arm/Group Title	Arm 1 - AZD3199 1400 μg	Arm 2 - AZD3199 880 μg	Arm 3 - AZD3199 800 μg	Arm 4 - AZD3199 300 μg	Arm 5 - AZD3199 1200 μg	Arm 6 - Placebo
Arm/Group Description	AZD3199 1400 μg SID	AZD3199 880 μg SID	AZD3199 800 μg SID	AZD3199 300 μg Turbuhaler inhaler	AZD3199 1200 μg Turbuhaler inhaler	Placebo
Measure Participants	25	25	25	25	25	25
Mean (Standard Deviation) [Liters]	3.448 (0.709)	3.453 (0.739)	3.495 (0.730)	3.448 (0.732)	3.569 (0.761)	3.310 (0.723)

3. Secondary Outcome

Title	tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit
Description	Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.
Time Frame	0 - 24 hrs.

Outcome Measure Data

Analysis Population Description

PD analysis set

Arm/Group Title	Arm 1 - AZD3199 1400 μg	Arm 2 - AZD3199 880 μg	Arm 3 - AZD3199 800 μg	Arm 4 - AZD3199 300 μg	Arm 5 - AZD3199 1200 μg	Arm 6 - Placebo
Arm/Group Description	AZD3199 1400 μg SID	AZD3199 880 μg SID	AZD3199 800 μg SID	AZD3199 300 μg Turbuhaler inhaler	AZD3199 1200 μg Turbuhaler inhaler	Placebo
Measure Participants	25	25	25	25	25	25
Median (Full Range) [Hours]	2.000	2.000	2.000	1.000	4.000	10.000

4. Secondary Outcome

Title	E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.
Description	Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.
Time Frame	FEV1 at 5 min

Outcome Measure Data

Analysis Population Description

PD analysis set

Arm/Group Title	Arm 1 - AZD3199 1400 μg	Arm 2 - AZD3199 880 μg	Arm 3 - AZD3199 800 μg	Arm 4 - AZD3199 300 μg	Arm 5 - AZD3199 1200 μg	Arm 6 - Placebo
Arm/Group Description	AZD3199 1400 μg SID	AZD3199 880 μg SID	AZD3199 800 μg SID	AZD3199 300 μg Turbuhaler inhaler	AZD3199 1200 μg Turbuhaler inhaler	Placebo
Measure Participants	25	25	25	25	25	25
Mean (Standard Deviation) [Liters]	3.406 (0.743)	3.449 (0.663)	3.496 (0.692)	3.489 (0.653)	3.486 (0.723)	3.188 (0.586)

5. Secondary Outcome

Title	E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit
Description	Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.
Time Frame	0 - 24 hrs

Outcome Measure Data

Analysis Population Description

PD analysis set

Arm/Group Title	Arm 1 - AZD3199 1400 μg	Arm 2 - AZD3199 880 μg	Arm 3 - AZD3199 800 μg	Arm 4 - AZD3199 300 μg	Arm 5 - AZD3199 1200 μg	Arm 6 - Placebo
Arm/Group Description	AZD3199 1400 μg SID	AZD3199 880 μg SID	AZD3199 800 μg SID	AZD3199 300 μg Turbuhaler inhaler	AZD3199 1200 μg Turbuhaler inhaler	Placebo
Measure Participants	25	25	25	25	25	25
Mean (Standard Deviation) [Liters]	3.489 (0.710)	3.526 (0.737)	3.537 (0.729)	3.493 (0.707)	3.636 (0.776)	3.287 (0.671)

6. Secondary Outcome

Title	Emax: Maximum Value of Pulse for Every Treatment Visits
Description	Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.
Time Frame	0 - 4 hrs.

Outcome Measure Data

Analysis Population Description

PD analysis set

Arm/Group Title	Arm 1 - AZD3199 1400 μg	Arm 2 - AZD3199 880 μg	Arm 3 - AZD3199 800 μg	Arm 4 - AZD3199 300 μg	Arm 5 - AZD3199 1200 μg	Arm 6 - Placebo
Arm/Group Description	AZD3199 1400 μg SID	AZD3199 880 μg SID	AZD3199 800 μg SID	AZD3199 300 μg Turbuhaler inhaler	AZD3199 1200 μg Turbuhaler inhaler	Placebo
Measure Participants	26	25	25	25	25	25
Mean (Standard Deviation) [Beats/min]	66.15 (11.10)	64.36 (10.10)	64.24 (9.27)	64.84 (10.18)	66.20 (12.38)	64.12 (11.22)

7. Secondary Outcome

Title	E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit
Description	Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.
Time Frame	0 - 4 hrs.

Outcome Measure Data

Analysis Population Description

PD analysis set

Arm/Group Title	Arm 1 - AZD3199 1400 μg	Arm 2 - AZD3199 880 μg	Arm 3 - AZD3199 800 μg	Arm 4 - AZD3199 300 μg	Arm 5 - AZD3199 1200 μg	Arm 6 - Placebo
Arm/Group Description	AZD3199 1400 μg SID	AZD3199 880 μg SID	AZD3199 800 μg SID	AZD3199 300 μg Turbuhaler inhaler	AZD3199 1200 μg Turbuhaler inhaler	Placebo
Measure Participants	26	25	25	25	25	25
Mean (Standard Deviation) [Beats/min]	59.85 (9.13)	59.13 (8.83)	59.07 (8.38)	58.77 (8.66)	59.73 (9.63)	58.66 (10.40)

8. Secondary Outcome

Title	Cmax: Maximum Plasma Concentration
Description	Maximum plasma concentration (Cmax) for AZD3199 doses
Time Frame	0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.

Outcome Measure Data

Analysis Population Description

PK analysis set

Arm/Group Title	Arm 1 - AZD3199 1400 μg	Arm 2 - AZD3199 880 μg	Arm 3 - AZD3199 800 μg	Arm 4 - AZD3199 300 μg	Arm 5 - AZD3199 1200 μg	Arm 6 - Placebo
Arm/Group Description	AZD3199 1400 μg SID	AZD3199 880 μg SID	AZD3199 800 μg SID	AZD3199 300 μg Turbuhaler inhaler	AZD3199 1200 μg Turbuhaler inhaler	Placebo
Measure Participants	26	25	25	25	25	0
Mean (Standard Deviation) [nmol/L]	6.93846 (2.497151)	5.81240 (2.497151)	6.29560 (2.827910)	3.01836 (1.294151)	13.54120 (4.337208)

9. Secondary Outcome

Title	AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC),
Description	Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses
Time Frame	0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.

Outcome Measure Data

Analysis Population Description

PK analysis set

Arm/Group Title	Arm 1 - AZD3199 1400 μg	Arm 2 - AZD3199 880 μg	Arm 3 - AZD3199 800 μg	Arm 4 - AZD3199 300 μg	Arm 5 - AZD3199 1200 μg	Arm 6 - Placebo
Arm/Group Description	AZD3199 1400 μg SID	AZD3199 880 μg SID	AZD3199 800 μg SID	AZD3199 300 μg Turbuhaler inhaler	AZD3199 1200 μg Turbuhaler inhaler	Placebo
Measure Participants	26	25	25	25	25	0
Mean (Standard Deviation) [nmol*h/L]	21.83501 (10.43729)	20.21716 (10.19966)	22.80110 (11.71379)	10.25880 (4.886541)	37.48982 (13.11484)

10. Secondary Outcome

Title	Tmax:Time to Maximum Plasma Concentration
Description	Time to maximum plasma concentration (tmax), for AZD3199 doses
Time Frame	0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.

Outcome Measure Data

Analysis Population Description

PK analysis set

Arm/Group Title	Arm 1 - AZD3199 1400 μg	Arm 2 - AZD3199 880 μg	Arm 3 - AZD3199 800 μg	Arm 4 - AZD3199 300 μg	Arm 5 - AZD3199 1200 μg	Arm 6 - Placebo
Arm/Group Description	AZD3199 1400 μg SID	AZD3199 880 μg SID	AZD3199 800 μg SID	AZD3199 300 μg Turbuhaler inhaler	AZD3199 1200 μg Turbuhaler inhaler	Placebo
Measure Participants	26	25	25	25	25	0
Median (Full Range) [Hours]	0.47000	0.48000	0.52000	0.52000	0.48000

11. Secondary Outcome

Title	t1/2 :Terminal Half-life
Description	Terminal half-life (t1/2),for AZD3199 doses
Time Frame	0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.

Outcome Measure Data

Analysis Population Description

PK analysis set

Arm/Group Title	Arm 1 - AZD3199 1400 μg	Arm 2 - AZD3199 880 μg	Arm 3 - AZD3199 800 μg	Arm 4 - AZD3199 300 μg	Arm 5 - AZD3199 1200 μg	Arm 6 - Placebo
Arm/Group Description	AZD3199 1400 μg SID	AZD3199 880 μg SID	AZD3199 800 μg SID	AZD3199 300 μg Turbuhaler inhaler	AZD3199 1200 μg Turbuhaler inhaler	Placebo
Measure Participants	9	8	8	8	9	0
Mean (Standard Deviation) [Hours]	80.97301 (24.65131)	79.24210 (22.07879)	103.7279 (113.8432)	77.46496 (47.17895)	88.99700 (46.23237)

Adverse Events

Arm/Group Title	AZD3199 1400 μg		AZD3199 880 μg		AZD3199 800 μg		AZD3199 300 μg		AZD3199 1200 μg		Placebo
Arm/Group Description	AZD3199 1400 μg SID		AZD3199 880 μg SID		AZD3199 800 μg SID		AZD3199 300 μg Turbuhaler inhaler		AZD3199 1200 μg Turbuhaler inhaler		Placebo
All Cause Mortality
	AZD3199 1400 μg		AZD3199 880 μg		AZD3199 800 μg		AZD3199 300 μg		AZD3199 1200 μg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	AZD3199 1400 μg		AZD3199 880 μg		AZD3199 800 μg		AZD3199 300 μg		AZD3199 1200 μg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/25 (0%)		0/25 (0%)		0/25 (0%)		0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	AZD3199 1400 μg		AZD3199 880 μg		AZD3199 800 μg		AZD3199 300 μg		AZD3199 1200 μg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/26 (34.6%)		9/25 (36%)		7/25 (28%)		7/25 (28%)		14/25 (56%)		6/25 (24%)
Gastrointestinal disorders
VOMITING	0/26 (0%)		2/25 (8%)		0/25 (0%)		0/25 (0%)		0/25 (0%)		0/25 (0%)
Infections and infestations
NASOPHARYNGITIS	5/26 (19.2%)		0/25 (0%)		3/25 (12%)		3/25 (12%)		5/25 (20%)		4/25 (16%)
Nervous system disorders
DYSGEUSIA	4/26 (15.4%)		5/25 (20%)		6/25 (24%)		4/25 (16%)		6/25 (24%)		0/25 (0%)
HEADACHE	2/26 (7.7%)		3/25 (12%)		2/25 (8%)		0/25 (0%)		4/25 (16%)		2/25 (8%)
Respiratory, thoracic and mediastinal disorders
COUGH	0/26 (0%)		0/25 (0%)		1/25 (4%)		1/25 (4%)		2/25 (8%)		0/25 (0%)
THROAT IRRITATION	0/26 (0%)		1/25 (4%)		0/25 (0%)		0/25 (0%)		2/25 (8%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.