Methacholine

Overview

Asthma is a complex condition associated with phenomena such as airway hyperresponsiveness (AHR), in which the smooth muscle in the airways (ASM) excessively contracts in response to stimuli, reducing pulmonary function and causing symptoms such as difficulty breathing. Although the underlying pathology of AHR is complex, ASM contraction can be stimulated by cholinergic agonists that activate M muscarinic receptors that stimulate ASM contraction. Methacholine is a non-specific cholinergic agonist (parasympathomimetic) that acts through muscarinic receptors in the lungs to induce bronchoconstriction. In patients with AHR, a lower dose of methacholine is required to induce bronchoconstriction, which forms the basis for the methacholine challenge test to diagnose AHR. Methacholine was granted FDA approval on October 31, 1986, and is marketed under the trademark PROVOCHOLINE® by Methapharm Inc.

Indication

Methacholine is indicated in adult and pediatric patients aged five years and older without clinically apparent asthma for the diagnosis of bronchial airway hyperactivity via the methacholine challenge test.

Associated Conditions

Bronchial airway hyperreactivity

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate the Sensitivity and Specificity of Inhaled Methacholine in Bronchial Provocation Test	2022/12/02	NCT05634473	Not Applicable	UNKNOWN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
The Effect of Deep Inhalation on Mannitol Responsiveness	2018/04/23	NCT03505489	Phase 3	Completed	University of Saskatchewan
Sensory-Mechanical Responses to Eucapneic Voluntary Hyperventilation and Mannitol	2017/04/10	NCT03105843	Phase 4	Recruiting	Dr. Diane Lougheed
Asthma Exacerbations and Vascular Function	2015/12/15	NCT02630511	Not Applicable	Completed	University of Alberta
Assessment of Airway Responsiveness and Treatment Efficacy in Asthmatics	2015/10/14	NCT02574975	Phase 4	UNKNOWN	Zhujiang Hospital
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BEA 2180 BR in Healthy Male Subjects	2014/10/15	NCT02263976	Phase 1	Completed	Boehringer Ingelheim
A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma	2014/03/31	NCT02100267	Phase 3	Completed	Sanwa Kagaku Kenkyusho Co., Ltd.
Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma	2014/03/27	NCT02097537	Phase 3	Completed	Santen Pharmaceutical Co., Ltd.
Comparison of the Methacholine PC20 Between the Trudell Aeroeclipse* II Ban Nebulizer and the Wright Nebulizer	2013/08/09	NCT01919424	Not Applicable	Completed	McMaster University
Dose-Response of Salmeterol in Children	2013/07/24	NCT01907334	Phase 4	Completed	University of Florida

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Provocholine	Methapharm Inc.	64281-100	RESPIRATORY (INHALATION)	100 mg in 100 mg	7/14/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
METHACHOLINE CHLORIDE, USP	panda pharmaceuticals inc.	02468271	Powder For Solution - Inhalation	160 MG / VIAL	N/A
METHACHOLINE CHLORIDE, USP	panda pharmaceuticals inc.	02468298	Powder For Solution - Inhalation	320 MG / VIAL	N/A
METHACHOLINE OMEGA	omega laboratories limited	02263890	Powder For Solution - Inhalation	100 MG / VIAL	3/27/2006
METHACHOLINE CHLORIDE, USP	panda pharmaceuticals inc.	02468301	Powder For Solution - Inhalation	1280 MG / VIAL	N/A
STERILE PROVOCHOLINE SOLUTION 16	Methapharm Inc	02283743	Solution - Inhalation	16 MG / ML	N/A
METHACHOLINE CHLORIDE, USP	panda pharmaceuticals inc.	02468263	Powder For Solution - Inhalation	100 MG / VIAL	N/A
PROVOCHOLINE	Methapharm Inc	02246493	Powder For Solution - Inhalation	320 MG / VIAL	3/12/2003
PROVOCHOLINE	Methapharm Inc	02243834	Powder For Solution - Inhalation	1280 MG / VIAL	9/24/2001
PROVOCHOLINE	Methapharm Inc	02239656	Powder For Solution - Inhalation	100 MG / VIAL	4/1/1999
PROVOCHOLINE	Methapharm Inc	02288826	Powder For Solution - Inhalation	1600 MG / VIAL	2/28/2008

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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