A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis

• Sponsor: Vertex Pharmaceuticals Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03911713
• Collaborator: (none)
• Enrollment: 77
• Locations: 48
• Arms: 5
• Actual Duration (Months): 16.1
• Patients Per Site: 1.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Drug: VX-561; Drug: IVA; Drug: Placebo; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
• Actual Study Start Date: Apr 17, 2019
• Actual Primary Completion Date: Aug 20, 2020
• Actual Study Completion Date: Aug 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ivacaftor Participants received IVA 150 milligrams (mg) orally every 12 hours (q12h) in the treatment period for 12 weeks.	Drug: IVA; 150-mg film-coated tablet for oral administration.; Other Names: VX-770 Ivacaftor ; Drug: Placebo; Placebos matched to VX-561.
Experimental: VX-561: 25 mg Participants received VX-561 25 mg orally daily (qd) in the treatment period for 12 weeks.	Drug: VX-561; VX-561 tablets for oral administration.; Other Names: CTP-656 Deutivacaftor (D-IVA) ; Drug: Placebo; Placebo matched to IVA.
Experimental: VX-561: 50 mg Participants received VX-561 50 mg orally qd in the treatment period for 12 weeks.	Drug: VX-561; VX-561 tablets for oral administration.; Other Names: CTP-656 Deutivacaftor (D-IVA) ; Drug: Placebo; Placebo matched to IVA.
Experimental: VX-561: 150 mg Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.	Drug: VX-561; VX-561 tablets for oral administration.; Other Names: CTP-656 Deutivacaftor (D-IVA) ; Drug: Placebo; Placebo matched to IVA.
Experimental: VX-561: 250 mg Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.	Drug: VX-561; VX-561 tablets for oral administration.; Other Names: CTP-656 Deutivacaftor (D-IVA) ; Drug: Placebo; Placebo matched to IVA.

Outcome Measures

Primary Outcome Measures

1. Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) [From Baseline at Week 12]

   FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.

Secondary Outcome Measures

1. Absolute Change in Sweat Chloride (SwCl) [From Baseline at Week 12]

   Sweat samples were collected using an approved collection device.

2. Observed Pre-Dose Concentration (Ctrough) of VX-561 and Its Metabolites (M1-VX-561 and M6-VX-561) and IVA and Its Metabolites (M1-IVA and M6-IVA) [At Week 4]

3. Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to Week 16]

Eligibility Criteria

Criteria

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

Key Inclusion Criteria:

• Must have 1 of the following 9 CFTR mutations on at least 1 allele: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D

• On ivacaftor therapy

• FEV1 value ≥40% and ≤100% of predicted mean for age, sex, and height

Key Exclusion Criteria:

• History of clinically significant cirrhosis with or without portal hypertension

• History of solid organ or hematological transplantation

• Lung infection with organisms associated with a more rapid decline in pulmonary status

Other protocol defined Inclusion/Exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Banner University of Arizona Medical Center	Tucson	Arizona	United States	85724
3	Miller Children's Hospital / Long Beach Memorial	Long Beach	California	United States	90806
4	UCSF Gateway Medical Center	San Francisco	California	United States	94143
5	National Jewish Health	Denver	Colorado	United States	80206
6	University of Miami Miller School of Medicine	Miami	Florida	United States	33136
7	Central Florida Pulmonary Group, PA	Orlando	Florida	United States	32803
8	Indiana University	Indianapolis	Indiana	United States	46202
9	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
10	University of Kentucky	Lexington	Kentucky	United States	40536
11	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
12	Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center	Boston	Massachusetts	United States	02114
13	Boston Children's Hospital	Boston	Massachusetts	United States	02115
14	Michigan Medicine	Ann Arbor	Michigan	United States	48109-5212
15	University of Minnesota	Minneapolis	Minnesota	United States	55455
16	Cardinal Glennon Children's Hospital	Saint Louis	Missouri	United States	63104
17	Washington University School of Medicine / St. Louis Children's Hospital	Saint Louis	Missouri	United States	63110
18	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
19	Columbia University Medical Center	New York	New York	United States	10032
20	University of North Carolina Hospitals	Chapel Hill	North Carolina	United States	27514
21	UC Health Holmes	Cincinnati	Ohio	United States	45220
22	ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center	Toledo	Ohio	United States	43606
23	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
24	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
25	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15224
26	Medical University of South Carolina	Charleston	South Carolina	United States	29425
27	Dell Children's Medical Group	Austin	Texas	United States	78723
28	The University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
29	University of Utah / Primary Children's Medical Center	Salt Lake City	Utah	United States	84132
30	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792
31	The Prince Charles Hospital	Chermside		Australia
32	Alfred Hospital	Melbourne, VIC		Australia
33	Mater Adult Hospital	South Brisbane		Australia
34	Westmead Hospital	Westmead		Australia
35	Universitair Ziekenhuis Gent	Gent		Belgium
36	Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital	Erlangen		Germany
37	Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen	Essen		Germany
38	Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie	Halle		Germany
39	Pneumologisches Studienzentrum Muenchen-West	Muenchen		Germany
40	University Hospital Wuerzburg	Würzburg		Germany
41	Cork University Hospital	Dublin 12		Ireland
42	Beaumont Hospital	Dublin 9		Ireland
43	St. Vincent's University Hospital	Dublin		Ireland
44	University Hospital Limerick (Adults)	Limerick		Ireland
45	UMC St. Radboud	Nijmegen		Netherlands
46	Clinical Research Facility, Queen Elizabeth University Hospital	Glasgow		United Kingdom
47	St. James University Hospital	Leeds		United Kingdom
48	Liverpool Heart and Chest Hospital	Liverpool		United Kingdom

Sponsors and Collaborators

• Vertex Pharmaceuticals Incorporated

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 3, 2019
• Statistical Analysis Plan - Jan 24, 2020

More Information

Publications

None provided.

• Responsible Party: Vertex Pharmaceuticals Incorporated
• ClinicalTrials.gov Identifier: NCT03911713
• Other Study ID Numbers: VX18-561-101; 2018-003970-28
• First Posted: Apr 11, 2019
• Last Update Posted: Jan 25, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cystic Fibrosis; Fibrosis; Ivacaftor

Study Results

Participant Flow

Pre-assignment Detail	This study was conducted in cystic fibrosis (CF) participants aged 18 years or older who have a gating mutation and were previously taking stable dose of ivacaftor (IVA).

Arm/Group Title	Ivacaftor	VX-561: 25 mg	VX-561: 50 mg	VX-561: 150 mg	VX-561: 250 mg
Arm/Group Description	Participants received IVA 150 milligrams (mg) orally every 12 hours (q12h) in the treatment period for 12 weeks.	Participants received VX-561 25 mg orally once daily (qd) in the treatment period for 12 weeks.	Participants received VX-561 50 mg orally qd in the treatment period for 12 weeks.	Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.	Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.
Period Title: Overall Study
STARTED	12	6	11	24	24
Full Analysis Set	11	6	11	23	24
COMPLETED	11	4	11	22	24
NOT COMPLETED	1	2	0	2	0

Baseline Characteristics

Arm/Group Title	Ivacaftor	VX-561: 25 mg	VX-561: 50 mg	VX-561: 150 mg	VX-561: 250 mg	Total
Arm/Group Description	Participants received IVA 150 mg orally q12h in the treatment period for 12 weeks.	Participants received VX-561 25 mg orally qd in the treatment period for 12 weeks.	Participants received VX-561 50 mg orally qd in the treatment period for 12 weeks.	Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.	Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.	Total of all reporting groups
Overall Participants	11	6	11	23	24	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.3 (11.7)	33.0 (10.6)	27.8 (9.0)	32.5 (8.5)	37.4 (11.4)	33.5 (10.4)
Sex: Female, Male (Count of Participants)
Female	4 36.4%	2 33.3%	3 27.3%	8 34.8%	9 37.5%	26 34.7%
Male	7 63.6%	4 66.7%	8 72.7%	15 65.2%	15 62.5%	49 65.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	1 9.1%	1 4.3%	0 0%	2 2.7%
Not Hispanic or Latino	11 100%	6 100%	10 90.9%	22 95.7%	24 100%	73 97.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	1 9.1%	0 0%	0 0%	0 0%	0 0%	1 1.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
White	10 90.9%	6 100%	11 100%	23 100%	24 100%	74 98.7%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (percentage points) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage points]	74.0 (21.2)	63.6 (22.4)	66.8 (17.4)	72.6 (17.3)	73.9 (17.0)	71.6 (18.0)

Outcome Measures

1. Primary Outcome

Title	Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Description	FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Time Frame	From Baseline at Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all randomized participants who have intended CF transmembrane conductance regulator gene (CFTR) genotype and received at least 1 dose of study drug in treatment period. VX-561:25 mg and VX-561:50 mg arms were discontinued at sponsor's discretion and it was specified in statistical plan that data will be reported for only IVA, VX-561:150 mg and VX-561:250 mg arms for this outcome measure.

Arm/Group Title	Ivacaftor	VX-561: 150 mg	VX-561: 250 mg
Arm/Group Description	Participants received IVA 150 mg orally q12h in the treatment period for 12 weeks.	Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.	Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.
Measure Participants	11	23	24
Least Squares Mean (95% Confidence Interval) [percentage points]	-0.8	3.1	2.7

2. Secondary Outcome

Title	Absolute Change in Sweat Chloride (SwCl)
Description	Sweat samples were collected using an approved collection device.
Time Frame	From Baseline at Week 12

Outcome Measure Data

Analysis Population Description

FAS. VX-561:25 mg and VX-561:50 mg arms were discontinued at sponsor's discretion and it was specified in statistical plan that data will be reported for only IVA, VX-561:150 mg and VX-561:250 mg arms for this outcome measure.

Arm/Group Title	Ivacaftor	VX-561: 150 mg	VX-561: 250 mg
Arm/Group Description	Participants received IVA 150 mg orally q12h in the treatment period for 12 weeks.	Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.	Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.
Measure Participants	11	23	24
Least Squares Mean (95% Confidence Interval) [millimole per liter (mmol/L)]	0.9	3.3	-6.5

3. Secondary Outcome

Title	Observed Pre-Dose Concentration (Ctrough) of VX-561 and Its Metabolites (M1-VX-561 and M6-VX-561) and IVA and Its Metabolites (M1-IVA and M6-IVA)
Time Frame	At Week 4

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) set included all participants who received at least 1 dose of study drug and for whom the primary PK data were considered to be sufficient and interpretable. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluable for the specific category.

Arm/Group Title	Ivacaftor	VX-561: 25 mg	VX-561: 50 mg	VX-561: 150 mg	VX-561: 250 mg
Arm/Group Description	Participants received IVA 150 mg orally q12h in the treatment period for 12 weeks.	Participants received VX-561 25 mg orally qd in the treatment period for 12 weeks.	Participants received VX-561 50 mg orally qd in the treatment period for 12 weeks.	Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.	Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.
Measure Participants	9	4	7	20	20
VX-561: Week 4	26.1 (24.7)	123 (61.6)	458 (273)	1100 (856)
M1-VX-561: Week 4	18.1 (17.7)	108 (58.6)	378 (213)	739 (407)
M6-VX-561: Week 4	NA (NA)	59.8 (34.0)	211 (189)	370 (233)
IVA: Week 4	952 (766)
M1-IVA: Week 4	1330 (774)
M6-IVA: Week 4	662 (398)

4. Secondary Outcome

Title	Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

Safety Set included all participants who received at least 1 dose of study drug.

Arm/Group Title	Ivacaftor	VX-561: 25 mg	VX-561: 50 mg	VX-561: 150 mg	VX-561: 250 mg
Arm/Group Description	Participants received IVA 150 mg orally q12h in the treatment period for 12 weeks.	Participants received VX-561 25 mg orally qd in the treatment period for 12 weeks.	Participants received VX-561 50 mg orally qd in the treatment period for 12 weeks.	Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.	Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.
Measure Participants	11	6	11	23	24
Participants with AEs	8 72.7%	4 66.7%	8 72.7%	21 91.3%	23 95.8%
Participants with SAEs	1 9.1%	2 33.3%	2 18.2%	2 8.7%	1 4.2%

Adverse Events

Time Frame	Baseline up to Week 16
Arm/Group Title	Ivacaftor		VX-561: 25 mg		VX-561: 50 mg		VX-561: 150 mg		VX-561: 250 mg
Arm/Group Description	Participants received IVA 150 mg orally q12h in the treatment period for 12 weeks.		Participants received VX-561 25 mg orally qd in the treatment period for 12 weeks.		Participants received VX-561 50 mg orally qd in the treatment period for 12 weeks.		Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.		Participants received VX-561 250 mg orally qd in the treatment period for 12 weeks.
All Cause Mortality
	Ivacaftor		VX-561: 25 mg		VX-561: 50 mg		VX-561: 150 mg		VX-561: 250 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Serious Adverse Events
	Ivacaftor		VX-561: 25 mg		VX-561: 50 mg		VX-561: 150 mg		VX-561: 250 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/11 (9.1%)		2/6 (33.3%)		2/11 (18.2%)		2/23 (8.7%)		1/24 (4.2%)
Gastrointestinal disorders
Distal intestinal obstruction syndrome	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis	1/11 (9.1%)		1/6 (16.7%)		2/11 (18.2%)		2/23 (8.7%)		1/24 (4.2%)
Investigations
Forced expiratory volume decreased	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Ivacaftor		VX-561: 25 mg		VX-561: 50 mg		VX-561: 150 mg		VX-561: 250 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/11 (72.7%)		4/6 (66.7%)		8/11 (72.7%)		17/23 (73.9%)		20/24 (83.3%)
Blood and lymphatic system disorders
Leukocytosis	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Cardiac disorders
Palpitations	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Ear and labyrinth disorders
Ear pain	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Tinnitus	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Eye disorders
Glaucoma	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Gastrointestinal disorders
Abdominal distension	0/11 (0%)		0/6 (0%)		0/11 (0%)		2/23 (8.7%)		1/24 (4.2%)
Abdominal pain	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Abdominal pain lower	1/11 (9.1%)		0/6 (0%)		1/11 (9.1%)		0/23 (0%)		0/24 (0%)
Abdominal pain upper	0/11 (0%)		0/6 (0%)		0/11 (0%)		2/23 (8.7%)		0/24 (0%)
Constipation	1/11 (9.1%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Duodenitis	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Gastrooesophageal reflux disease	0/11 (0%)		0/6 (0%)		0/11 (0%)		2/23 (8.7%)		0/24 (0%)
Nausea	1/11 (9.1%)		1/6 (16.7%)		1/11 (9.1%)		0/23 (0%)		0/24 (0%)
Vomiting	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
General disorders
Chest discomfort	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Fatigue	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Malaise	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Pyrexia	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Infections and infestations
Bronchopulmonary aspergillosis allergic	0/11 (0%)		0/6 (0%)		1/11 (9.1%)		0/23 (0%)		0/24 (0%)
Epididymitis	0/11 (0%)		0/6 (0%)		1/11 (9.1%)		0/23 (0%)		0/24 (0%)
Fungal skin infection	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Infective pulmonary exacerbation of cystic fibrosis	2/11 (18.2%)		0/6 (0%)		2/11 (18.2%)		2/23 (8.7%)		4/24 (16.7%)
Nasopharyngitis	2/11 (18.2%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		3/24 (12.5%)
Oral candidiasis	1/11 (9.1%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		1/24 (4.2%)
Sinusitis	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		2/24 (8.3%)
Upper respiratory tract infection	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		1/23 (4.3%)		2/24 (8.3%)
Injury, poisoning and procedural complications
Contusion	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Investigations
Alanine aminotransferase increased	0/11 (0%)		1/6 (16.7%)		1/11 (9.1%)		0/23 (0%)		1/24 (4.2%)
Aspartate aminotransferase increased	0/11 (0%)		1/6 (16.7%)		2/11 (18.2%)		1/23 (4.3%)		1/24 (4.2%)
Atypical mycobacterium test positive	0/11 (0%)		0/6 (0%)		1/11 (9.1%)		0/23 (0%)		0/24 (0%)
Bacterial test positive	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Blood creatine phosphokinase increased	1/11 (9.1%)		0/6 (0%)		2/11 (18.2%)		0/23 (0%)		1/24 (4.2%)
Blood glucose increased	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Coronavirus test positive	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Forced expiratory volume decreased	0/11 (0%)		1/6 (16.7%)		1/11 (9.1%)		0/23 (0%)		0/24 (0%)
Protein urine present	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Pulmonary function test decreased	0/11 (0%)		0/6 (0%)		1/11 (9.1%)		0/23 (0%)		0/24 (0%)
Urine ketone body present	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Weight decreased	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Metabolism and nutrition disorders
Hyperglycaemia	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Hyperkalaemia	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/11 (0%)		1/6 (16.7%)		0/11 (0%)		0/23 (0%)		1/24 (4.2%)
Back pain	0/11 (0%)		0/6 (0%)		0/11 (0%)		2/23 (8.7%)		0/24 (0%)
Musculoskeletal chest pain	0/11 (0%)		0/6 (0%)		1/11 (9.1%)		0/23 (0%)		0/24 (0%)
Nervous system disorders
Dizziness	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		1/24 (4.2%)
Headache	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		1/23 (4.3%)		0/24 (0%)
Migraine	0/11 (0%)		0/6 (0%)		0/11 (0%)		2/23 (8.7%)		1/24 (4.2%)
Sinus headache	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	2/11 (18.2%)		1/6 (16.7%)		1/11 (9.1%)		6/23 (26.1%)		1/24 (4.2%)
Dyspnoea	0/11 (0%)		2/6 (33.3%)		0/11 (0%)		2/23 (8.7%)		0/24 (0%)
Haemoptysis	0/11 (0%)		0/6 (0%)		0/11 (0%)		3/23 (13%)		1/24 (4.2%)
Increased viscosity of bronchial secretion	0/11 (0%)		0/6 (0%)		1/11 (9.1%)		0/23 (0%)		0/24 (0%)
Lower respiratory tract congestion	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		2/23 (8.7%)		1/24 (4.2%)
Nasal congestion	2/11 (18.2%)		1/6 (16.7%)		1/11 (9.1%)		2/23 (8.7%)		1/24 (4.2%)
Oropharyngeal pain	2/11 (18.2%)		0/6 (0%)		0/11 (0%)		4/23 (17.4%)		0/24 (0%)
Paranasal sinus discomfort	0/11 (0%)		0/6 (0%)		1/11 (9.1%)		1/23 (4.3%)		0/24 (0%)
Pulmonary pain	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		0/24 (0%)
Rales	0/11 (0%)		1/6 (16.7%)		1/11 (9.1%)		1/23 (4.3%)		1/24 (4.2%)
Respiration abnormal	2/11 (18.2%)		0/6 (0%)		1/11 (9.1%)		4/23 (17.4%)		0/24 (0%)
Sputum increased	0/11 (0%)		0/6 (0%)		1/11 (9.1%)		4/23 (17.4%)		3/24 (12.5%)
Skin and subcutaneous tissue disorders
Dermatitis contact	0/11 (0%)		0/6 (0%)		1/11 (9.1%)		0/23 (0%)		0/24 (0%)
Hyperhidrosis	0/11 (0%)		0/6 (0%)		1/11 (9.1%)		0/23 (0%)		2/24 (8.3%)
Rash	1/11 (9.1%)		0/6 (0%)		0/11 (0%)		0/23 (0%)		2/24 (8.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.